Supplier & Operations Quality Engineer
About The Position
Basic Job Purpose:
Lumenis is 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, You’ll 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 Lumenis 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, QBR’s 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 SOP’s & WI’s update.
- Systems refurbishing committees at subcontractors.
- Supporting internal CAPA processes and actions.
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/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.
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