Basic Job Purpose: Lead of quality activities of the surgical platforms.
Cover all quality aspects related to production, Process control and improvement, data collection and analysis. Quality investigations and training/qualification session to production, Support QA transfer to production from development stages, Support QA transfer of production sites.
Main Duties:
•Supporting all quality activities in products, quality events in production
•Ensure the quality of deliverable parts/materials and services by the suppliers.
•Data collection and analyzing – periodic reports and trend analysis %28MRB, complaints, Yield%29
•Product final release activities
•Quality meetings lead, preparation and summary distribution per line of products %28platform%29, Quarterly quality Reports, QBR’s and presentations.
•Involve in quality processes improvements.
•Complaint trending per platform on quarterly basis
•Field complaint investigations. General quality investigations.
•Quality plans pFMEA’s initiation and maintenance for new or modified production processes.
•FAI for new parts & projects related to engineering changes. %28cost reduction, production transfer etc.%29
•Support of process and test method validation activities for transferred and updated manufacturing processes and sites.
•Supplier corrective action request %28SCAR%29 initiation and follow-up.
•QA SOP’s update.
•Supplier Audits and certification.
•Quality related trainings to production people.
•Define KPI and crucial activities supporting quality engineers for Production line transfer processes and qualificationMain Duties:
•Supporting all quality activities in products, quality events in production
•Ensure the quality of deliverable parts/materials and services by the suppliers.
•Data collection and analyzing – periodic reports and trend analysis %28MRB, complaints, Yield%29
•Product final release activities
•Quality meetings lead, preparation and summary distribution per line of products %28platform%29, Quarterly quality Reports, QBR’s and presentations.
•Involve in quality processes improvements.
•Complaint trending per platform on quarterly basis
•Field complaint investigations. General quality investigations.
•Quality plans pFMEA’s initiation and maintenance for new or modified production processes.
•FAI for new parts & projects related to engineering changes. %28cost reduction, production transfer etc.%29
•Support of process and test method validation activities for transferred and updated manufacturing processes and sites.
•Supplier corrective action request %28SCAR%29 initiation and follow-up.
•QA SOP’s update.
•Supplier Audits and certification.
•Quality related trainings to production people.
•Define KPI and crucial activities supporting quality engineers for Production line transfer processes and qualification
Required Qualifications:
•At least 4 years of experience in a similar role.
•Experience with: Multidiscipline products & medical devices.
•Ability of Approving test protocols and V&V %28production related only%29
•Knowledge in Process Validation, pFMEA
•Knowledge of product Life Cycle methods and control, medical standards /regulations and general standards knowledge %28for example: ISO13485, FDA – QSR, MDD, IEC 60601, etc.’%29
•Familiar with Failure analysis and statistic techniques methods and Expertise
•Multi-tasking and objective dedication
•Good leadership skills & interpersonal relationship
