Supplier & Ops. QA Engineer

Main Duties:

• Lead quality processes & activities in a production line of products.
• Cover all quality aspects related to production, Process control and improvement, data collection and analysis. Quality investigations and training/qualification session to production at sub-contractors, Support QA transfer to production from development stages, Support QA transfer of production sites (TK & FTK).
• Supporting all quality activities in products, quality events in production line at sub-contractors.
• Ensure the quality of deliverable parts/materials and services by the suppliers.
• Data collection and analyzing – periodic reports and trend analysis (MRB, Complaints, Yield)
• Product final release activities
• Quality meetings lead, preparation and summary distribution per line of products (platform), Quarterly quality Reports, QBR’s and presentations.
• Lead quality process improvement.
• Supporting all quality activities in production, quality event investigation.
• Supporting non-conforming material control and MRB
• Complaint trending per platform on quarterly basis - Field complaint investigations. General quality investigations
• pFMEAs establish/update per products and maintenance at least once a year.
• FAI for new parts & projects related to engineering changes (Cost reduction, production transfer etc.)
• Execution of process and test method validation activities for transferred and updated manufacturing processes and sites.
• Supplier Audits and certification.
• Supplier corrective action request (SCAR) initiation and follow-up.
• Quality related training for production employees.
• QA SOP’s & WI’s update.
• Systems refurbishing committees at sub-contractors

Requirements:

• Quality education – CQM or CQE Or Master’s degree.
• Minimum of 5 years of experience in Quality.
• Experience with: Multidiscipline products & medical devices.
• Ability of approving test protocols and V&V (production related only)
• Knowledge in Process Validation, pFMEA
• Knowledge of product Life Cycle methods and control, medical standards /regulations and general standards knowledge (for example: ISO13485, FDA – QSR, MDD, IEC 60601, etc.’)
• Familiar with Failure analysis and statistic techniques methods and Expertise
• Multi-tasking and objective dedication
• Good interpersonal relationship