דרושים QA Engineer ביקנעם

Manage ECOs: conduct risk assessments, update relevant DMR s 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.

Bachelor of Science degree or Engineering.

3-5 years of experience in medical device QA (ISO 13485, MDSAP, FDA QSR 820).

Internal auditor certification- an advantage

Ability to work in dynamic and multi-interfaced surroundings, micro and macro vision.

Strong attention to details and Self-learning ability.

Ability to manage time and priorities and work under pressure.

English - high level (both written and spoken).

Excellent leadership and people management skills.

Service oriented.

Knowledge and practical experience in Priority – An advantage.