Quality Assurance Production Specialist
HemoCue AB / Kemiingenjörsjobb / Ängelholm
Observera att sista ansökningsdag har passerat.
Visa alla kemiingenjörsjobb i Ängelholm,
Åstorp,
Bjuv,
Bräcke,
Båstad eller i
hela Sverige Visa alla jobb hos HemoCue AB i Ängelholm,
Lund,
Stockholm eller i
hela Sverige HemoCue, sedan april 2013 en del av Radiometer Group, är ett världsledande företag inom patientnära testning. HemoCue AB, beläget i Ängelholm, introducerade 1982 det första patientnära hemoglobintestet. Företaget säljer även patientnära tester för glukos, urinalbumin, HbA1c, totala antalet vita blodkroppar (B-LPK) och 5-partsdiff. Besök vår hemsida för mer information hemocue.com
The Quality Assurance group is part of the RA/QA department and responsible for quality assurance and quality development activities within the core processes Supply Chain Management, Product Lifecycle Management and Customer Relationship Management. This includes QA support during production and also further development of the already released products and manufacturing processes, handling of non-conformities and complaints as well as the qualification and maintenance of suppliers.
We are now looking for a Quality Assurance Production Specialist who will work together with production and QC department. The tasks include, but are not limited to, review and approval of material disposition related to non-conformities, to be a QA representative in process- and software validations as well as review & approval of QC reports.
Key Responsibilities
• Ensure that activities, within production and QC, are in compliance with the requirements in ISO 13485:2003, QSR, ISO 14001, environmental laws and legislations as well as industry best practices
• Maintain and ensure compliance to the non-conformance procedure
• Ensure material disposition and release of products through individual NCRs and Final Release Board
• Ensure that activities, within VMP and assigned projects, related to Process Validations, Software and Method Validations are in compliance with requirements in ISO 13485:2003 and QSR as well as industry best practice.
Requirements
• University degree in science or technology (Master or Bachelor)
• A minimum of five years of experience from Medical Device Industry or similar, including experience in:
- Handling of non-conformities
- Process and software validations
• Strong communication skills (verbal as well as in writing) in both English and Swedish
• Problem solving skills
• Ability to understand medical device regulations and standards
WHY HEMOCUE?
HemoCue is a company that gives a unique opportunity from a quality perspective. Being a global leader and serving over 100 countries in the world with POCT products of highest quality gives the employees great challenges and experience the right candidate may find longer term development opportunities beyond HemoCue.
Questions regarding the position should be directed to Ann Jönsson, 0431-48 15 52.
For union information, contact Annelie Kjellman, Unionen, 0431-48 12 13 or Simone Åkermo, Akademikerklubben, 0431-48 12 15.
Send your application via
www.hemocue.com/jobsidan latest 2014-11-24. We are unable to accept your application in other ways than through our Jobs page. Any request by mail or email will be returned.
Publiceringsdatum2014-11-05Arbetstider och omfattning40 timmar i veckan Efter överenskommelse
ErsättningEfter överenskommelse
Så ansöker duSista dag att ansöka är 2014-11-24
Klicka på denna länk för att göra din ansökanKontaktAnn Jönsson +46 0431-48 15 52
FöretagHemoCue AB
AdressHemoCue AB
Box 1204
26223 Ängelholm
KontorsadressKuvettgatan 1
Övriga kontaktuppgifter Jobbnummer 2056027
Observera att sista ansökningsdag har passerat.