QA Engineer

Responsibilities:

• ECO Management: Conduct risk assessments, update relevant DMR documents, and carry out necessary IQ, OQ, and PQ activities for engineering change orders (ECOs).
• DCO Management: Write and update QA procedures in the PLM system to ensure compliance with quality standards and regulatory requirements.
• NCR and CAPA Management: Lead, write, and supervise the NCR and CAPA processes to ensure timely and effective resolutions.
• QA Production Support: Provide quality support to production operations, addressing deviations and non-conformities to maintain high product quality.
• Issue Resolution: Ensure timely resolution of quality issues to prevent delays and maintain efficient operations.
• Audit Participation: Take part in internal and external audits, such as FDA inspections and notified body audits based on ISO 13485, EUMDR, and MDSAP requirements.

Requirements:

• Education: Bachelor of Science degree or Engineering.
• Experience: 2-5 years of experience in medical device QA (ISO 13485, FDA QSR 820).
• Certification: Internal auditor certification (preferred).
• Skills: Ability to work in dynamic and multi-interfaced environments, strong attention to detail, self-learning ability, time management, and priority setting skills.
• Language: English (high level, both written and spoken).
• Leadership: Excellent leadership and people management skills.
• Service Orientation: Service-oriented approach.
• Knowledge: Knowledge and practical experience in Priority (preferred).