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Life Science, Chemical and Food is a team specialized in profiles with a scientific and engineering background in Manufacturing, Production, Engineering, SCM, R&D, Medical, Quality and Technical-Sales in Pharma, Chemical Pharmaceutical, Biotech, Chemical, Cosmetic, Medical, Plastic Rubber, Food.
Leading Medical multinational company based in the Modena Area
Senior QA R&D Engineer
As a Senior QA R & D Engineer (m / w / d) you ensure that new product designs are in compliance to applicable internal procedures, as well as international regulations and standards in order to guarantee devices safety and effectiveness. In addition, you actively support new project teams for the product development and improvement of medical devices as a "cross-functional employee".
- Represent the quality of the project core teams for new problem development and sustaining (including labeling)
- In cooperation with R&D, accountable for product compliance to standards and regulations
- Responsible for creating and maintaining project / product quality plans for the entire product lifecycle.
- Proactive work to establish global processes in accordance with existing or new international regulations and requirements.
- Provide focused quality engineer support as well as the responsibility and coordination of assigned project activities
- Provide quality inputs for business initiatives such as feasibility studies, project design phases, field actions
- Development and implementation of the quality system in the Lead quality system throughout the entire product life cycle
- Approval of technical documentation (e.g., test reports, test reports, design reviews, risk management files),
- Approval of Risk management files, including evaluation for new and / or modified products and processes
Location: Modena Area
- Successfully completed Master's Degree in Engineering (preferably Biomedicine)
- 6-7 years of experience in the medical technology industry, ideally in the area of quality assurance, in alternative in product development of finally sterile disposables or R&D organization
- Experience in design and quality processes
- Experience with the standards of medical devices / ISO 13485 as well as with MDD (and ideally MDR)
- Knowledge of 21 CFR 820 (Quality Systems Medical Devices), especially Part 30, ISO14791, and other medical standards.
- Experience with quality tools and statistical programs such as Minitab, Risk Assessment (FMEA, FTA, HACCP..), Experimental Design (DOE) and Process Improvement (SPC).
- Audit experience
- Very good knowledge of English in spoken and written
- High communication ability
- Fluent in English (French is considering a plus)
Please send your CV at: firstname.lastname@example.org
Ref: Senior QA R & D Engineer
Applications considered relevant to the research will be contacted within 30 days of receipt of the application.
For all others who want to send their CV, we will consider the professional profile for future opportunities.