Quality assurance manager, Köping
Dfind Science & Engineering AB / Kemistjobb / Köping
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On behalf of SGS DNA we are now looking for a Quality Assurance Manager for an interesting 12 months assignment in a growing company that during 2019 will move to a new a larger location in Västerås.
Dfind Science & Engineering is a consulting and recruitment company specialized in science and technology skills. We arrange various events and training courses for our consultants that enable exchange of experience, networking and insight into working in different roles and companies. With us, you get a consultant manager who is committed to your assignment and career development. For this role we also welcome self-employed applicants.
SGS DNA is a reputable company that is part of the QIAGEN Group. The company is located in Köping and has 60 employees. They work with customized medical devices for primarily diagnostics (IVD) but also other applications. The company also provides certain related services such as analysis and stability studies. They are focused on international markets for molecular diagnostic and other areas of medical applications like personalized healthcare.
Position Description
• As the QA Manager you are responsible for the Quality Management System and related processes of SGS
• Budget and leadership responsibility for a motivated team of 5 coworkers
• Member of SGS management team
Position Requirements
• Ensuring that GMP work is done in compliance with applicable guidelines (e.g. cGMP, 21 CFR Part 11, ISO9001, ISO13485)
• Running Quality Assurance processes (e.g. complaints, deviations, CAPA, changes, etc.)
• Management of projects to improve procedures and establish standards
• Responsibility to conduct regulatory inspections and customer audits
• Reviewing of relevant regulatory submissions
• Providing guidance and day-to-day support for the QA team
Personal Requirements
• 3 + years Quality Assurance experience for a Medical Device manufacturer or similar
• Degree in a biological, chemistry or comparable disciplines
• Good knowledge about - cGMP, FDA 21 CFR 820
• Proofed leadership skills
• Effective communication and negotiation skills
• Effective decision making
• Good knowledge of MS office, ideally experiences with QMS software, LIMS
• Good Swedish and English knowledge, fluent in spoken and written
• Preferably knowledge about LEAN and Continuous Improvement Processes
Business: Dfind Science & Engineering
City: Köping/Västerås
Job type: Full time. The position is a fixed term from end of March 2019 until March 2020 and can either be a temporary position or a permanent position with a 6 months' probation period. For this role we also welcome self-employed applicants.
Deadline for applications: 2019-02-04
The position is a fixed term from end of March 2019 until March 2020. We encourage you to send your application as soon as possible, since interviews and candidate selection are done continuously! We put great emphasis on personal suitability for this role.
More information: Benita Hyllbrant,
benita.hyllbrant@dfind.se Organization/Business description:
Dfind Science & Engineering is part of Randstad, one of the Nordic region's largest specialists within staffing, recruitment and outplacement.
Dfind Science& Engineering is specialized in recruitment and consulting providing competences within Life Science, Science and Engineering and is a company where people make all the difference. At Dfind Science & Engineering specialists are recruiting specialists!
All our recruitment consultants , consultants and sourcing managers have a technical or scientific background, combined with extensive networks within relevant communities and expertise within recruitment and HR. We understand our customers specific requirements and know how to find the best candidates. Through our passionate commitment and high degree of attentiveness we help people and businesses to grow and be competitive in a changing world.
Varaktighet, arbetstid
Heltid Tillsvidare
Publiceringsdatum2019-01-14ErsättningFast lön
Så ansöker duSista dag att ansöka är 2019-02-04
Ange följande referens när du ansöker: 201197580
Klicka på denna länk för att göra din ansökanKontaktBenita Hyllbrant
benita.hyllbrant@dfind.seFöretagDfind Science & Engineering AB
AdressDfind Science & Engineering AB
Regeringsgatan 65
11156 STOCKHOLM
KontorsadressRegeringsgatan 65, 11156 STOCKHOLM
Jobbnummer 4554992
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