Senior Quality Engineer

The position is based full time onsite on the Eastern side of Galway City.

Key Responsibilities

• Manufacturing Quality Support: Lead quality assurance efforts during in-house manufacturing, including overseeing lot release and ensuring compliance with rigorous standards.
• Quality Management System Development: Contribute to the development and implementation of quality plans, programmes, and procedures for product commercialisation to build quality at every stage.
• Regulatory Compliance: Ensure all work aligns with company quality policies and regulatory standards, supporting ISO 13485 and FDA CFR 820 requirements.
• Quality Assurance & Reporting: Conduct thorough analysis and reporting on quality discrepancies, ensuring robust corrective actions for product design and manufacturing processes.
• Supplier Quality Control: Collaborate with OEM contractors and vendors to maintain high quality standards across external component manufacturing.
• Audit & Regulatory Support: Support FDA and Notified Body audits, assisting with compliance documentation and non-conformity responses as needed.

Candidate Requirements

• Educational Background: Bachelor’s degree in Engineering or Science is required; a Master’s or PhD is preferred.
• Industry Experience: Minimum of 5 years’ experience in the medical device industry or equivalent through advanced study.
• Technical Skills: Demonstrated expertise in medical device quality and regulatory systems, with essential knowledge of ISO 13485 and FDA CFR 820.
• Additional Skills: Strong project planning, communication, and technical writing skills, with a fundamental understanding of engineering principles.
• Preferred Knowledge: Familiarity with cleanroom and sterilisation procedures and prior experience with process validation are advantageous

For more on this contact Johanne at 086 4403725 or choices@hero.ie

Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/

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