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Job Description
Quality Engineer sought for medical device development and manufacturing company in Sligo, Ireland. Key responsibilities include ensuring compliant product specifications, reviewing process validation plans, and maintaining compliant product risk management files.
Our clients are leaders in medical device development and manufacturing, serving both the European and US markets. They provide an exciting, dynamic work environment focused on career growth and employee wellness.
Key Responsibilities:
- Provide technical quality support to Project Managers, Engineers, and clients.
- Collaborate with teams to ensure compliant product specifications.
- Review process validation plans, protocols, and reports.
- Maintain compliant product risk management files.
- Oversee lot records for manufacturing and release of sterile products.
- Ensure compliance of SOPs, work instructions, and material specifications.
- Support non-conformance investigations and CAPA reports.
- Assist clients with regulatory submissions (FDA, MDR).
- Conduct internal audits and assist in external audit preparations.
Requirements:
- Degree in Science or Engineering.
- 3-5 years of experience in medical devices.
- Strong knowledge of ISO 13485 and FDA regulations.
- Experience with regulatory submissions and quality systems.
- Good communication, attention to detail, and problem-solving skills.
Benefits:
- Flexitime
- Paid Holidays
- Canteen
- Parking
- Pension
- Compressed hours