we are a global leader in energy-based solutions for Aesthetics and Eye Care. With more than 1000 employees worldwide and sales in over 100 countries, we are headquartered in Yokneam and have offices in Tel-Aviv.
We are looking for a Supplier & Operations Quality Engineer for the QA team, Youll 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).
Main Duties:
Supporting all quality activities in products, quality events investigation in production line at sub-contractors.
Ensure the quality of deliverable parts/materials and services by the suppliers.
Data collection and analysis - periodic reports and trend analysis (MRB, Complaints, Yield).
Perform Incoming inspections for materials / products that arrived in our company as part of verification of purchased products.
Product final release activities include DHR review for systems and accessories.
Review of & approve e-DHR conversion activities with FTK sub-contractors including validation final approval.
Quality meetings lead, preparation and summary distribution per line of products (platform), Quarterly quality Reports, QBRs and presentations.
Lead quality process improvement.
Supporting non-conforming material control and MRB.
Complaint trending per platform on a quarterly basis - Field complaint investigations.
pFMEAs establish/update per product and maintenance at least once a year.
QA Plan and report preparation and execution.
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 subcontractors.
Supporting internal CAPA processes and actions.
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/MDR, IEC 60601, GMP etc.).
Familiar with Failure analysis and statistic techniques methods and Expertise.
Proficient in English (writing, reading, and speaking).
Multi-tasking and objective dedication.
Good interpersonal relationship.
This position is open to all candidates.