Quality assurance within the medical device sect
ÅF-Industry AB, Malmö / Kemiingenjörsjobb / Malmö
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hela Sverige About the company
ÅF is an engineering and consulting company for the energy, industrial and infrastructure markets, creating progress for our clients since 1895. By connecting technologies we provide profitable, innovative and sustainable solutions to shape the future and improve people's lives. Building on our strong base in Europe, our business and clients are found all over the world.
ÅF ? Innovation by experience.
About the job
Your task will be to improve the quality and reliability of the medical device product developments and the coordination of all QA and RA activities within development projects for the entire life cycle of products.
You will also:
• Coordinate QA activities in a product development project between the different involved functions of the project team.
• Establishe and maintains Quality Plans in development projects (to cover QA aspects related to product design, process development and purchasing, with inclusion of quality KPIs and metrics) for new/changed products.
• Monitor and reviews timely and effective execution of the Quality plan including fulfillment of KPIs and metrics.
• Evaluate production and post-production information from current products and ensures that this information is handled as input to new/changed product developments.
• Periodically report to Manager QA/RA Solutions about the status of activities under his/her responsibility.
• Participate and/or chairs in Design Reviews.
• Participate during audits/inspections.
• Support and consult during the development of procedures for product development, product risk management and product registration.
• Review and/or approve Clinical Evaluation, Conformity to applicable standard, Field Trials Protocols/Report, clinical trial protocols/reports and user consultation reports.
• Review and approves sampling plans and statistical analyses of test results. Consult and advise others as needed.
• Review Design History File in depth prior to final design reviews and ensures DHF readiness in cooperation with the Design owner and provides recommendation for CE Marking and Field Trial execution.
• Review and approve labeling material incl. Marketing Material for the assigned productq Review and approve Design Review Reportsq Release of the product within final design review.
• Release for first human use/Sales under Prescriptionq Reject and vetoe deliverables which are not adequate, not based on objective evidence or not compliant to regulatory requirements.
• Reject and vetoe Design reviews, if needed.
Who are you?
Requirements:
• Bachelor Degree or equivalent in science or engineering
• Quality Management and/or regulatory affairs education for medical devices/drugs is preferred
• Knowledge in quality engineering methods would be preferred (e.g. QFD, DoE, statistical techniques, Six Sigma, Root Cause Analysis, Pareto, Ishikawa, Risk Management and more.
• Fluent in English written and spoken.
• Independent, solution oriented, analytical thinking
• Ability to work as an independent person in a team or independently.
• Good Communication skills and ability to discuss with partners on a peer level
• Min. of 3 years experience in medical device industry, pharmaceutical industry and/or quality and regulatory position is preferred.
• Project leader experience is preferred
• Knowledge of appropriate regulations/standards for medical devices / drugs
We also want your resume and cover letter in English.
Publiceringsdatum2015-12-21KörkortskravB
Varaktighet, arbetstid
Tillsvidare
Heltid
ErsättningFast och rörlig lön
Så ansöker duKlicka på denna länk för att göra din ansökanFöretagÅF-Industry AB, Malmö
AdressÅF-Industry AB, Malmö
BOX 585
20125 MALMÖ
KontorsadressHALLENBORGS GATA 1A
MALMÖ
Övriga kontaktuppgifterTelefonnummer: 010-505 00 00
Jobbnummer 2587438
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