Quality Assurance Specialist
HemoCue AB / Kemiingenjörsjobb / Ängelholm
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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
Our Quality Assurance department needs reinforcement; therefore we are looking for a Quality Assurance Specialist.
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 and Product Lifecycle Management. This includes QA expertise during product development, production and also further development of the already released products and manufacturing processes, handling of non-conformities as well as the qualification and maintenance of suppliers.
The Job
To become successful, you must support the organization with QA expertise by cooperating cross-functionally with other departments. Your main responsibilities and tasks will include:
Ensure that activities, within production and QC, are in compliance with the requirements in ISO 13485, 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 and QSR as well as industry best practice.
Qualifications
You have an University degree in science or technology (Master or Bachelor)
Experience from the following areas is required:
Minimum three years of experience in QA Production from medical device industry or similar, including experience in: Handling of non-conformities Process Validations
Knowledge in ISO 13485 and QSR 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
Personality
As a person you are you takes initiative and are a team player, efficient, structured and solution-oriented and who likes a fast pace. You find it easy to communicate with other people and enjoy working in a company that is driven by continuous improvement, both in terms of equipment and processes.
Interviews will be held as soon as relevant candidates have been identified
Interviews will be held as soon as relevant candidates have been identified. Send your application via
www.hemocue.com/jobbsidan . We are not able to receive your application by other means than through "jobbsidan". Please bring diplomas for face-to-face interviews. Any application by mail or e-mail will be returned.
We offer you
A unique opportunity to work in the field of medical technologies, where knowledge sharing and professional respect combine to make it both fun and meaningful to go to work.
Both in Sweden and abroad you will meet enthusiastic colleagues who take pride in making a difference in a company whose products can truly impact other people's lives. Also we offer you opportunities for training and career development.
We are looking forward to receiving your application.
For further information, please contact Quality Assurance Manager, Anna Stegmark at tel. +46 734 14 05 50.
Union information is available from Patrik Heimby, Unionen, +46 431-48 14 10 or Lars Bergman, Akademikerföreningen, +46 431-48 15 60.
Varaktighet, arbetstid
Enligt överenskommelse Efter överenskommelse
Publiceringsdatum2016-08-19ErsättningEnligt överenskommelse
Så ansöker duSista dag att ansöka är 2016-09-19
Klicka på denna länk för att göra din ansökanKontaktAnna Stegmark +46 431-481550, +46 734-140550
FöretagHemoCue AB
AdressHemoCue AB
Box 1204
26223 Ängelholm
KontorsadressKuvettgatan 1
Övriga kontaktuppgifter Jobbnummer 3001528
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