Quality Assurance Engineer

We are seeking a skilled and detail-oriented QA Engineer to join our team. The ideal candidate will be responsible for executing quality assurance activities, managing quality projects, and participating in process and product validations to ensure compliance with established standards and regulatory requirements. The QA Engineer will work closely with cross-functional teams to support quality projects, provide manufacturing support, and drive continuous improvement initiatives across the organization.

SCOPE & RESPONSIBILITIES:

Manage ECOs: 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.

2-5 years of experience in medical device QA (ISO 13485, FDA QSR 820).

Internal auditor certification- an advantage

English - high level (both written and spoken).

Knowledge and practical experience in Priority – An advantage.