Position

Quality Engineer

QA&RA

Tel Aviv

Full-time

What will you do?

Provide Quality Engineering support to various teams in product realization cycle.
Provide quality and compliance guidance for process owners responsible for design, development and production of medical devices
Assist with defining and documenting deliverables in DHF / DHR files in accordance with internal procedures / work instructions and in compliance with applicable quality and regulatory requirements
Develop and Implement processes for product execution and Product/Process Verification and Validation policies and procedures
Provide guidance and decisions on Design, Development and Manufacturing activities in compliance with internal procedure and regulatory requirements
Take active role in risk management activities (DFMEA/PFMEA).
Write and review product and process verification and validation protocols and reports
Overall responsibility for DHF and DHR contents assuring full traceability
Handling non-conformities detected in production and participate in MRB committee
Review DMR and manufacturing documents, work instructions and procedures, engineering/design change reports (ECOs) and provide inputs related to QA/QC.
Identify opportunities to proactively assure compliance to international quality regulations e.g., ISO 62304 ISO 13485, ISO14971, US 21 CFR 820 etc.
Define and implement process control & process monitoring methods for continuous improvement

Bachelor’s degree in engineering/Scientific field
3+ years of experience in Quality Assurance at Medical Device companies (active implants companies – an advantage)
Familiarity with international quality regulations –ISO 13485, ISO 14971, US 21 CFR 820 etc.
Ability to partner with R&D / Manufacturing departments and collaborate with various departments within the organization
Experience in implementing and guide quality standards in day-to-day activity
Experience in writing and reviewing manufacturing procedures/ work instructions/ forms related to manufacturing processes.
Experience in writing and reviewing engineering/design changes (ECO).
Experience in product and process validation, test method validation, statistics, risk management tools
Experience handling non-conformities (NCR/MRB) in production.
An ability to successfully communicate and educate QMS regulations, policies, and strategies to employees at all levels of the organization
Languages: English – excellent level