we are a fast-growing medical device company focused on developing, manufacturing, and selling innovative devices for endovascular interventional procedures. Were looking for a QA Engineer to support and strengthen our manufacturing quality. In this role, youll work closely with cross-functional teams, execute day-to-day quality activities on the manufacturing floor and help drive continuous improvement in a hands-on, fast-paced environment.
LOCATION: Yokneam, Israel.
SCOPE & RESPONSIBILITIES
* Manage ECOs: conduct risk assessments, update relevant DMR documents and carry out necessary IQ, OQ, PQ activities if required, finalization of implementation tasks.
* Manage DCOs in the PLM system : Write and update QA procedures to ensure compliance with quality standards and regulatory requirements.
* Manage NCR and CAPA processes: Lead, write and supervise the NCR and CAPA processes, ensuring timely and effective resolutions.
* Manage QA production activities: Provide quality support to production operations, addressing deviations and non-conformities to maintain high product quality.
* Ensure Timely Resolution of Quality Issues: Promptly address all identified or assigned quality issues to prevent delays and maintain efficient operations.
* Participate in audits: Take part in internal and external audits, such as FDA inspections and notified body audits based on ISO13485, EUMDR, and MDSAP requirements.
* Manage Supplier quality: Manage supplier qualification and performance monitoring, including SCAR management, and support supplier audits.

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.