Required Supplier & Ops. QA Engineer
Description:
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, QBRs 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 SOPs & WIs update.
Systems refurbishing committees at sub-contractors.
Description:
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, QBRs 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 SOPs & WIs update.
Systems refurbishing committees at sub-contractors.
Requirements:
Quality education CQM or CQE Or Masters 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.
Quality education CQM or CQE Or Masters 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.
This position is open to all candidates.
