SCOPE & RESPONSIBILITIES

• Manage ECOs: Lead a team to conduct risk assessment, 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.
• Ensuring 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.

REQUIREMENTS

• Bachelor of Science degree or Engineering.
• 5-7 years of experience in medical device QA (ISO 13485, FDA QSR 820).
• Knowledge and experience in manufacturing in clean rooms.
• Internal auditor certification.
• 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