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.
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.
Requirements:
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. Kno wledge and practical experience in Priority An advantage.
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. Kno wledge and practical experience in Priority An advantage.
This position is open to all candidates.
