Supplier & Ops. QA Engineer

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

·        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