Lediga jobb Civilingenjör, kvalitet, kemiteknik Helsingborg

Quality Control to Life Science Company | Helsingborg

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Are you looking for an exciting consulting assignment in Quality Control? We are currently seeking a dedicated and qualified individual with a degree in chemistry, microbiology, or a related field to our client in Helsingborg. This is your opportunity to work in a dynamic environment, focusing on chemical analyses and LC and GC. The assignment spans over 3 years, with an immediate start. Take a step into the future and apply today! Location: Helsingborg ... Visa mer

Are you looking for an exciting consulting assignment in Quality Control? We are currently seeking a dedicated and qualified individual with a degree in chemistry, microbiology, or a related field to our client in Helsingborg. This is your opportunity to work in a dynamic environment, focusing on chemical analyses and LC and GC. The assignment spans over 3 years, with an immediate start. Take a step into the future and apply today!

Location: Helsingborg
Start: Immediately
Assignment Duration: 3 years, this is a consultant assignment. You will be hired by Jefferson Wells and work for our client.

Job Description:

As a Quality Control consultant, you will be a key player in our clients team, responsible for ensuring high-quality chemical analyses. Your main tasks will be quality control of finished product and the laboratory mainly uses chromatographic analysis techniques. The primary data is documented/managed electronically in Labware/ LIMS (Laboratory Information Management System). Your work will be conducted in a fast-paced and diverse environment. Here are some of your main responsibilities:

* Perform and oversee various chemical analyses to ensure the quality of raw materials, intermediates, and finished products.
* Work with advanced instruments and techniques, such as Liquid Chromatography (LC) and Gas Chromatography (GC), to analyze chemical substances and monitor results.
* Accurately document all conducted analyses, results and report any deviations from quality standards.
* Follow and ensure compliance with quality control standards and regulations within the Life Science sector.
* Collaborate with other teams within Life Science, including research and development, as well as production, to ensure overall quality goals.

Requirements:

To succeed in the role of Quality Control consultant, we expect you to meet the following criteria:

* University degree in chemistry, microbiology, or a related field.
* Previous experience from lab and life science/pharma
* Experience in chemical analyses and familiarity with LC and GC processes.
* Fluent in Swedish and English, both written and spoken
* Ability to adapt to and thrive in a dynamic work environment.

Application:

Feel welcome to submit your application by registering your CV. Selection is ongoing, so do not hesitate to send in your application today. We do not accept applications via email. Visa mindre

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Senior Quality & Compliance Specialist GMP

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Job description Come join Kenvue as a Senior Quality & Compliance Specialist GMP. You will join a senior and tight knit team where they all contribute with different knowledge. Kenvue is on an exciting journey transitioning from a traditional pharmaceutical company to more of a consumer company. You could get the opportunity to be part of this journey in a work place where helpfulness, inclusion and working towards the same goals is for certain. You wil... Visa mer

Job description
Come join Kenvue as a Senior Quality & Compliance Specialist GMP. You will join a senior and tight knit team where they all contribute with different knowledge. Kenvue is on an exciting journey transitioning from a traditional pharmaceutical company to more of a consumer company. You could get the opportunity to be part of this journey in a work place where helpfulness, inclusion and working towards the same goals is for certain.

You will get to use your wide experience and contribute as a quality representative in supporting product development, ensuring that guidelines and SOP´s are followed. Audits will be another working area, e.g. leading internal audits and being the host for external audits. You will of course work in the QMS, managing and developing it. Change control and investigations are also part of the position. As is releasing products for clinical trials and consumer studies.

The team is led by a team-oriented manager who is supporting and guiding when needed and who lets the team own and drive their work.

You have the opportunity to work from home 2 days a week, as the company policy is set at the moment.

Please apply at www.randstad.se, no later than 2023-09-03. If you have questions, please contact recruitment consultant Karolina Andersson on [email protected].

For us, it is important that all competence and skills in the labor market are utilized. We welcome all applicants and strive for diversity.

Responsibilities
You will share your time approximately in half between supporting in product development projects in different ways and working in, managing and developing the QMS.

Qualifications
To be happy and thrive in this role, you bring the following knowledge and experience:

A minimum of a BSc in e.g. chemistry, pharmacy or other relevant area
Several years of working experience in a comparable role
Solid knowledge in GMP
Experience in working with external partners and suppliers
Excellent skills in English both in speech and in writing
Good knowledge in Swedish

It will be seen as a merit if you have the food business and in food supplement regulations and/or combination products. Also if you have knowledge in computer system validation. It is also a plus if you have experience in internal audits and being the host for external audits. Experience in releasing products for clinical trials and/or the market is also seen as a merit.

We believe that you are a team player, who have a helicopter perspective even if the job often invites you to dig in to detail in different areas. You are pragmatic and creative in your field and focus on finding the best solutions for all parties within set frames and regulations. You are comfortable in the global setting and understand the time frames in a pharmaceutical company.

About the company
At Kenvue, we believe there is extraordinary power in everyday care. Built on over a century of heritage and propelled forward by science, our iconic brands—including NEUTROGENA®, AVEENO®, TYLENOL®, LISTERINE®, JOHNSON’S® and BAND-AID® —are category leaders trusted by millions of consumers who use our products to improve their daily lives. Our employees share a digital-first mindset, an approach to innovation grounded in deep human insights, and a commitment to continually earning a place for our products in consumers’ hearts and homes. Visa mindre

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GCP Auditor, Helsingborg

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Job description Here is an opportunity to work in a global role as GCP Auditor at Johnson & Johnson Consumer Health, responsible for auditing trials in the EMEA region on the GCP and GLP regulations. You will work with products ranging from pharmaceuticals, cosmetics, OTC and Health technology. Contributing to the mission to build QA of the Future by transforming the BioResearch Quality & Compliance (BRQC) audit function to be industry-leading and to deliv... Visa mer

Job description
Here is an opportunity to work in a global role as GCP Auditor at Johnson & Johnson Consumer Health, responsible for auditing trials in the EMEA region on the GCP and GLP regulations. You will work with products ranging from pharmaceuticals, cosmetics, OTC and Health technology. Contributing to the mission to build QA of the Future by transforming the BioResearch Quality & Compliance (BRQC) audit function to be industry-leading and to deliver innovative ways to proactively secure compliance and drive sustainability and reliability across R&D.

Do you enjoy working independently, while having a wide range of contact areas both in and outside your organization? Is your passion to contribute to research by assuring that it is performed responsibly and with high quality? Then this might be your next role!

Responsibilities
Quality Assurance is responsible for the implementation and delivery of global cross-functional compliance audit programs to ensure that the development programs, Marketing Authorization Holders, functions, processes, and systems for Consumer (and all partners) are in compliance with company standards and Health Authority guidelines and regulations.

We are looking for a GCP Specialist who will be working in a global environment responsible for developing and maintaining quality systems and controls related to GCP and GLP regulations, policies and standards. You will be responsible for planning, conducting, and reporting of audits (e.g. external vendors, Trial Master Files, clinical investigator sites and documents). Furthermore you will perform and lead risk evaluations and base decisions on the outcome of the audits.

In this role you will get to work closely with external vendors, R & D, Regulatory Affairs, Operations, Procurement as well as with our Project Managers. In these collaborations you will provide expertise, training and guidance when needed. You will also collaborate on providing strategic direction for the R&D compliance group.

You will be the process owner for selected GCP & R&D compliance SOPs and also have the chance to contribute to process improvement and development of new auditing procedures, techniques and guidelines.

To succeed in this role it is important that you can lead yourself and others and that you are able to work proactively in the field of GCP and GLP. Most of the work is done digitally, but there are some travels throughout the year.

Qualifications
To be happy and thrive in this role we believe that you bring the following experience:

A relevant university degree
Extensive knowledge in the framework of GCP and/or GLP
A minimum of three years’ work experience working with GCP and/or GLP
Excellent skills in English both orally and in writing
Willingness to travel

We will be extra curious to learn more about you if you have experience in auditing and if you have experience working internationally. Knowledge in Swedish will also be a plus.

You enjoy working independently, whilst having a wide variety of contacts globally. We see that you are structured which helps you have an easy time adapting to different circumstances and environments. You are also communicative and and have a high sense of drive and motivation in your work.

For us, it is important that all competence and skills in the labor market are utilized. We welcome all applicants and strive for diversity.

About the company
Johnson & Johnson Consumer is one of the world's largest consumer health and personal care products company. Our consumer companies produce many of the world's most trusted brands, among them JOHNSON'S® Baby, BAND-AID®, NEUTROGENA®, TYLENOL®, MOTRIN®, and LISTERINE®. Each one of our consumer businesses embraces innovative science to create products that anticipate consumer needs and create experiences that help them live healthy, vibrant lives. Thriving on a diverse company culture, celebrating the uniqueness of our employees, and committed to inclusion. Proud to be an equal opportunity employer.

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo. We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we in Sweden are working to create an inclusive environment where a diverse set of backgrounds, perspectives and experiences are valued and each and every one of our people feel that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”! Visa mindre

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Söker nu en QA Specialist!

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RÅÅ S AB grundades 2011. Från början verkade RÅÅ S AB som ett innovationscenter som utvecklade nya produkter vilket resulterade i en produktionsanläggning för vår senaste innovation On! Det är ett helt vitt, tobaksfritt portionssnus som innehåller nikotin samt ingredienser som används i mat, kosttillskott och tuggummi. Under 2019 expanderade marknaden för helt vita tobaksfria snuspåsar kraftigt och företaget blev en del av Altria Group. Efterfrågan på det ... Visa mer

RÅÅ S AB grundades 2011. Från början verkade RÅÅ S AB som ett innovationscenter som utvecklade nya produkter vilket resulterade i en produktionsanläggning för vår senaste innovation On! Det är ett helt vitt, tobaksfritt portionssnus som innehåller nikotin samt ingredienser som används i mat, kosttillskott och tuggummi. Under 2019 expanderade marknaden för helt vita tobaksfria snuspåsar kraftigt och företaget blev en del av Altria Group. Efterfrågan på det tobaksfria snuset är väldigt hög och On! växer snabbt. On! finns idag tillgängligt i bl a Sverige, USA, Schweiz och Danmark. Vår verksamhet växer och utvecklas ständigt och idag arbetar ca 100 personer tillsammans som en multifunktionell enhet för att producera marknadens bästa produkter. Vi samarbetar för att driva företaget framåt och vi växer hela tiden.

RÅÅ S AB söker nu genom Amarelle & Partners en strukturerad och proaktiv QA Specialist som vill vara med på vidareutvecklingen av vår QA avdelning

Här erbjuds du en viktig roll i ett snabbt växande företag. Är du som person stabil och sporras av kvalitet och arbete med processer? Trivs du med att skapa struktur och att säkerställa kvalitet? Går du i gång på att arbeta i ett tillväxtbolag med hög fart och i förändring, där du har en nyckelposition i QA teamet på 11 personer? Vill du vara med och växla upp verksamheten till nya nivåer? Då har du här en fantastisk möjlighet!

Rollen

Som QA specialist (QA change control specialist) på RÅÅ S är dina främsta uppgifter att säkerställa och koordinera samt stötta projektägarna gällande change control processen och kvalifikationsarbete i produktionen. Du kommer ansvara för att supportera produktionspersonalen och teknikavdelningen utifrån vårt QMS system.

Arbetsuppgifter

- Styra över och hantera all dokumentation relaterad till change control processen

- Utveckla, implementera och administrera change control processer såväl som relaterade processer i vårt QMS system. Det kan gälla utrustnings- och systemkvalifikationer samt projektledningsprocesser.

- Övervaka statusen på pågående change control processer
Utbilda medarbetare i change control och kvalifikationsprocesser

Utbildning och erfarenhet

Krav

- Högskole- eller universitetsutbildning inom områdena natur eller teknik

- Minst 2 års arbetslivserfarenhet inom kvalitetssäkring

- Flytande svenska och engelska, såväl skriftligt som muntligt

Meriterande

- Erfarenhet av och förståelse för kvalitetssäkring

- Erfarenhet av processer för ändringshantering

- Erfarenhet av relevanta standarder och regelverk såsom ISO9001, ISO22000, FDA och FSSC

Personliga egenskaper

Som person är du självgående och drivs av att skapa struktur samt att implementera processer. För dessa uppgifter krävs också att du är noggrann och analytisk. Du är stabil och bidrar med positiv energi till teamet och övriga kollegor. Din samarbetsförmåga är avgörande liksom att på ett pedagogiskt och uthålligt sätt kunna verka för att processer följs. I perioder av högre belastning har du lätt för att avgöra vilka bollar du ska hålla i luften. För att passa in hos RÅÅ S AB är du prestigelös och gillar att ha kul på jobbet!

Ansökan
I denna rekrytering samarbetar vi med Amarelle & Partners. För frågor om tjänsten kontakta gärna rekryteringspartnern Martin Amarelle på [email protected].

Tänk på att din ansökan inte ska innehålla uppgifter kring hälsa, medborgarskap, sexuell läggning eller medlemskap i fackförening. Notera även att vi tyvärr inte kan ta emot CV via e-post.

Vi tillämpar löpande urval så ansök gärna idag. Varmt välkommen med din ansökan!

Start: Enligt överenskommelse

Placering: Helsingborg

Omfattning: Heltid Visa mindre

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Senior Quality Specialist, Helsingborg

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Job description Here´s an opportunity to join Johnson & Johnson Consumer Health as a Senior Quality Specialist. You will have the chance to work globally with a very exciting R&D projects within medical device. Getting to be an important part of the development by contributing with your expertise within the regulations and a quality focus in supplier management. Are you passionate about the consumer and their role in driving innovation to help people liv... Visa mer

Job description
Here´s an opportunity to join Johnson & Johnson Consumer Health as a Senior Quality Specialist. You will have the chance to work globally with a very exciting R&D projects within medical device. Getting to be an important part of the development by contributing with your expertise within the regulations and a quality focus in supplier management.

Are you passionate about the consumer and their role in driving innovation to help people live healthier lives? At Johnson & Johnson, we blend heart, science, and ingenuity to profoundly change the trajectory of health for humanity. Come join us, this might be your next role!

Responsibilities
You will get to join R&D Q&C at J&J where the team in Helsingborg that consists of 11 specialist, supports the local pilot plant, have compliance responsibility overseeing R&D and provide compliance guidance in new product development projects both in the region and globally.

This role will support Medical Device projects and products in the Self Care portfolio. You will have the opportunity to work closely with the Future of Selfcare R&D team supporting the identification, development and commercialization of ground-breaking innovation opportunities.

One of the main projects at hand is an exciting project where you will collaborate closely with a development team in the US. Here you will get to add value with you expertise in the EU-regulations and be part of supplier management where you will add knowledge concerning how requirements needs to be set up in order to be compliant.

In your assignments you will work closely with commercial, external innovation, IT, consumer and market research, business development, medical and regulatory partners to shape opportunities, perform diligence and create prototypes.

To sum up, some of your assignments will be:
• To be responsible for supporting Medical Device project and product development efforts by providing compliance guidance, participate as compliance representative and ensuring all devices meet applicable standards
• To collaborate with project teams to review and approve critical device development work streams, including risk assessment/risk management, design verification/validation protocols and reports, and technical documents for regulatory submissions
• To supervise guidelines and regulations to ensure J&J is using best practices

Qualifications
To have the right prerequisites and be happy in this position, we see that you bring the following experience:
• Relevant university degree
• A minimum of three years´ working experience within the quality field in medical device
• Extensive knowledge in the regulations for medical device
• Knowledge in electronics
• Experience in working with external suppliers
• Excellent skills in English

It will be seen as an advantage if you also have experience in the pharmaceutical industry. If you have skills in Swedish and/or Chinese, this will also be a plus.

Regarding your character skill set, we see that you drive your own work independently with a solution oriented mind based on an intellectual curiosity. You enjoy collaboration and building strong relations. We also believe that you like to bring new perspective, that you communicate effectively and stand firm in your opinion, when it concerns matters that cannot be compromised.

For us, it is important that all competence and skills in the labor market are utilized. We welcome all applicants and strive for diversity.

About the company
Johnson & Johnson Consumer is one of the world's largest consumer health and personal care products company. Our consumer companies produce many of the world's most trusted brands, among them JOHNSON'S® Baby, BAND-AID®, NEUTROGENA®, TYLENOL®, MOTRIN®, and LISTERINE®. Each one of our consumer businesses embraces innovative science to create products that anticipate consumer needs and create experiences that help them live healthy, vibrant lives. Thriving on a diverse company culture, celebrating the uniqueness of our employees, and committed to inclusion. Proud to be an equal opportunity employer.

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo. We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we in Sweden are working to create an inclusive environment where a diverse set of backgrounds, perspectives and experiences are valued and each and every one of our people feel that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”! Visa mindre

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Kvalitetschef

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Kemira söker en driven Kvalitetschef till produktionssiten i Helsingborg. Vi söker dig som är engagerad, noggrann och som är intresserad av att arbeta med kvalitets- och miljöledning i nära anslutning till både produktion, miljö och människor. Som Kvalitetschef ingår du i ett EHSQ-team och ansvarar för företagets standarder och ledningssystem. Du planerar och genomför internrevisioner av alla företagets ISO-standarder samt representerar siten vid extern- ,... Visa mer

Kemira söker en driven Kvalitetschef till produktionssiten i Helsingborg. Vi söker dig som är engagerad, noggrann och som är intresserad av att arbeta med kvalitets- och miljöledning i nära anslutning till både produktion, miljö och människor.
Som Kvalitetschef ingår du i ett EHSQ-team och ansvarar för företagets standarder och ledningssystem. Du planerar och genomför internrevisioner av alla företagets ISO-standarder samt representerar siten vid extern- , koncern-, och leverantörsrevisioner. Du fångar upp kund- och leverantörsreklamationer och ansvarar för inrapportering av uppgifter/statistik till olika delar av koncernen. I rollen ingår även att ansvara för företagets system för dokument- och avvikelsehantering samt leda utbildningsaktiviteter på siten.

Vi erbjuder:

· Ett varierande och utmanade jobb där du har huvudansvaret för att driva företagets kvalitetsledningsarbete utifrån gällande standarder och koncerndirektiv.
· Möjlighet att fortlöpande utveckla och förbättra sitens ledningsystem
· Ett arbete för dig som är intresserad av att arbeta med både praktiska och administrativa uppgifter
· En konkurrenskraftig lön och bra förmåner

Vi vill att du:

· Har relevant högskoleutbildning gärna med kemiinriktning och erfarenhet av kvalitetsledningsarbete inom processindustri eller annan tillverkande industri.
· Väl förtrogen med ISO 9000, ISO 14000, ISO 45000 samt ISO 50000
· Gedigen erfarenhet av både intern- och externrevisoner
· Har god samarbetsförmåga, gott omdöme, engagerad, noggrann samt har ordnings- och ansvarskänsla.
· Kommunicerar på ett enkelt, tydligt och rakt sätt
· Har ett högt säkerhetsmedvetande
· Behärskar vårt koncernspråk engelska och talar och skriver svenska mycket bra.

Upplysningar
Upplysningar om befattningen lämnas av sitechef Peter Kihlgren tel. 042-17 10 00. Facklig information lämnas av Ledarna/Patrik Eriksson 042-17 16 60, Akademikerna/Christoffer Ödman 042?17 11 86, Unionen/Martin Fridehjelm 042-171995, IF Metall/Kenth Hultin 042-171111

Ansökan
Du ansöker via vår hemsida, www,kemira.com, sista dag för ansökan är 25 maj Visa mindre

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R&D Quality Specialist GMP

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For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo. We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives ... Visa mer

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.
We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences
That is why we in Sweden are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each and every one of our people feel that they belong and can reach their potential. No matter who they are.
Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”!

About McNeil AB – Johnson & Johnson Consumer Health
At Johnson & Johnson Consumer Nordic, we have a truly unrivalled brand portfolio, with power brands across multiple categories, including Neutrogena, Natusan, Piz Buin, o.b, Imodium, Ipren, Livostin and Nicorette. In Helsingborg we manufacture Nicorette and Rhinocort products for the global market. Our Nicorette products - found in over 80 countries - help people around the world to quit tobacco and live healthier lives. In addition to manufacturing, we also have a global research and development unit working in three areas: Smoking Cessation, Digestive Health and Cough & Cold. With around 650 employees we are one of the region's largest companies. Products manufactured in Helsingborg are mostly over-the-counter pharmaceuticals and are produced, tested and released according to good manufacturing practices (GMP).

Introduction and Overview
R&D Q&C is part of the Regional Franchise Quality Self Care organization which is composed of 10 people in the region. The purpose and scope of this team is to ensure quality and compliance, that the application of GxP and Johnson & Johnson requirements to the products being developed, manufactured and used in clinical trials, is effective, safe and have the right quality to ensure that consumers and patients are not exposed to risk using these products.

R&D Quality Specialist GMP
New product development projects support in the Self Care Franchise spanning over product classifications of OTC (over-the-counter), Herbals, Medical Device/Combination product classification and Food Supplement. The activities span from early development and clinical trials to scale up and technical transfer activities. The Specialist GMP are responsible for
developing and maintaining quality systems and controls related to cGxP regulations and Johnson & Johnson policies and standards including development and implementation of new or revised procedures.
product development efforts by providing compliance guidance, participate as compliance representative, review and approve documentation related to projects and compliance, release of supplies to R&D studies, review and approve supplier management related documentation, etc.
validation and qualification activities of lab computer systems.
performing quality activity for Medical Device projects.

Qualifications - External
Bachelor’s degree is the minimum level with a degree in Chemistry, Pharmacy, Technical Engineering or equivalent in related subjects (required)
Experience in Pharmaceutical and/or Medical Device environment (required) from R&D environment (preferred)
Good language skills in local language and English both written and spoken (required)
The work environment is global and requires good networking and collaboration skills (required)
Experience from computerized system validation (merit)
Experience from quality system in relation to software development, especially App development with MD classification (merit)

What you will need to succeed
We are looking for a person who:
can lead his/her own work
masters collaborating with partners in an agile development environment
can understand the holistic view and at the same time is able to focus on details
is a standout colleague
solution oriented
has both technical and social competence.

What type of mark will YOU make?
By joining Johnson & Johnson you will find unlimited opportunities to build your path & amplify your impact inside & outside our walls. Our dedication to be the world’s healthiest workforce provides a range of opportunities to strengthen your body as well as your mind. When you work with us you can touch over a Billion lives worldwide every day, and when you apply your talent to our collective purpose there’s no end to the lasting impact we can make together and that changes everything.

Application
If you are interested in this position, please apply with an updated CV and Cover letter. The selection process will start during the standard 30-days posting period, please send in your application as soon as possible. We reserve the rights to close the advert earlier. All applicants can expect feedback on the application.
If you have issues applying, please use Chrome Web Browser and reset your password. If that does not help you can get more guidance and contact us from this page: https://www.careers.jnj.com/contactus-faq. Visa mindre

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QA/RA Manager, Helsingborg

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Job description Here is an exciting opportunity as a QA/RA Manager at Vigmed! You will get to add value and experience in a role that is both operational and strategical. Driving the QA and RA agenda, joining the management team in Sweden and also having an impact on the global project of achieving an MDR certification. Grab the chance to both learn and contribute! Responsibilities As a QA/RA Manager at Vigmed you will get to lead the QA/RA activities and... Visa mer

Job description
Here is an exciting opportunity as a QA/RA Manager at Vigmed! You will get to add value and experience in a role that is both operational and strategical. Driving the QA and RA agenda, joining the management team in Sweden and also having an impact on the global project of achieving an MDR certification. Grab the chance to both learn and contribute!

Responsibilities
As a QA/RA Manager at Vigmed you will get to lead the QA/RA activities and also manage the QA Engineer. As mentioned, you will be part of the Vigmed management team and have a central part and bring expertise in the global project, where Vigmed together with Greiner Bio-One will achieve a MDR certification. You will have the opportunity to be an influencer in the project all the way.

You will get to take ownership of the QMS system and ensure that it is in accordance with demands from MDD, ISO standards and requirements from Notified body. Later on, you will also be part to ensure that MDR and FDA requirements are fulfilled.

In development projects, you will have the opportunity to be the QA/RA representative and in general promote the awareness of regulatory and customer requirements throughout the organization.

Qualifications
To really thrive and be successful in the role and enjoy being a part of Vigmed, we believe that you bring the following experience:
• A minimum of a BSc degree within Life Sciences or Engineering
• At least five years of working experience in a QA and/or RA role in the Medtech and/or Life Science industry
• Experience in audits
• Excellent skills in English and proficiency in Swedish

It will be an advantage if you have experience in the Medtech industry and if you have experience as a leader, responsible for an area of expertise, in line management and/or in a management group. Also if you have knowledge in ISO13485, MDD, MDR and/or FDA. Education and experience in EtO sterilization will also be very useful and seen as a plus.

We believe that you will bring a teamwork spirit and that you enjoy working in the small company within the bigger company group. You drive and take ownership of your work and execute it with structure, thoroughness and fact driven decision making. You see the value of having a business perspective both in QA/RA but also in what you contribute with in the management group where you make use of you interest in numbers and strategic thinking.

For us, it is important that all competence and skills in the labor market are utilized. We welcome all applicants and strive for diversity.

Application
Selection and interviews will be ongoing, so we are curious to read your application as soon as possible.

If you have any questions, you are welcome to contact senior recruitment consultant Karolina Andersson at 0705736613 or [email protected].

About the company
Vigmed is a company within medical devices. We are situated in Helsingborg with a mission to eliminate needle stick injuries within healthcare during intravenous and arterial catherization. Our philosophy when developing the first range of products was to provide the health care workers with familiar, high quality, affordable products, which provide increased protection from needle sticks. Today, we market products for intravenous and arterial catheterization first launched in 2014 – all with an automatic safety function built-in. We have launched the products in all of Western Europe and selected markets outside Western Europe. Our short-term focus is to optimize our existing portfolio and longer term to innovate and establish best-in-class solutions in the market.

During 2017, Vigmed became part of Greiner Bio-One (GBO), which is a privately held, Austrian company within the Med Tech industry. Combining the innovative capabilities and “center of excellence” knowledge within Vigmed with GBOs market position and financial strength is expected to accelerate our growth even further. Visa mindre

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