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Supplier & Ops. QA Engineer

UNLIMITED HOLIDAYS

Remote:

Hybrid

Contract:

Full time

Experience:

Senior (5-10 years)

Work from:

Afula (IL)

Offer summary

Qualifications:

Master’s degree in Quality education or CQM/CQE, Minimum 5 years Quality experience in multidiscipline products.

Key responsabilities:

Lead quality processes in production line and sub-contractors
Ensure quality of deliverables from suppliers, lead QA meetings
Implement process control improvements, data analysis, product final release activities
Lead non-conforming material control, perform complaint investigations
Conduct audits, train production employees, update QA SOP's and WI's

Lumenis

1001 - 5000 Employees

See more Lumenis offers

Job description

Your missions

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, QBR’s 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 SOP’s & WI’s update.

· Systems refurbishing committees at sub-contractors

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, IEC 60601, etc.’)

· Familiar with Failure analysis and statistic techniques methods and Expertise

· Multi-tasking and objective dedication

· Good interpersonal relationship