Are you an experienced Supplier Quality Engineer seeking a new challenge in the medical device sector?
A global medical device manufacturer is looking for a talented professional to join their team in Galway. This is a fantastic opportunity to advance your career in an organisation dedicated to improving patient care.
Key Responsibilities:
1. Supplier Quality Management: Oversee the quality performance of externally sourced finished medical devices to ensure compliance with regulatory standards and the company’s stringent quality requirements.
2. Quality Issue Resolution: Investigate and resolve quality issues, particularly related to incoming inspections at distribution centres, and communicate effective solutions to suppliers.
3. Corrective Actions (CAPA): Work with suppliers to implement Corrective Actions for non-conformance issues and verify the effectiveness of corrective measures.
4. Supplier Audits & Assessments: Lead supplier assessments to ensure adherence to regulatory standards and the company’s quality expectations, offering guidance for supplier performance improvement.
5. Collaboration: Work closely with Supplier Engineering and Commercial Sourcing teams to meet quality, cost, and service objectives. Integrate suppliers into New Product Development (NPD) projects, ensuring quality deliverables are met.
6. Sustaining Quality & Process Changes: Support the resolution of sustaining quality issues and assist with design or process changes, ensuring seamless integration with supplier and internal quality systems.
7. Travel: Occasional domestic and international travel (up to 25%) to support supplier quality activities.
Key Qualifications:
1. Degree (Level 8) in Engineering or a related technical discipline.
2. 4+ years of experience in a regulated industry, ideally within medical device quality management.
3. Strong knowledge of QSR (Quality System Regulations), ISO standards, and experience with CAPA and SCAR processes.
4. Proficient in Microsoft Office (Excel, PowerPoint, Power BI) and Quality Management Systems (QMS).
5. Excellent communication (written and verbal) and problem-solving skills.
Desirable Qualifications:
1. Experience in supplier quality management within the medical device industry.
2. Knowledge of ISO 13485 and medical device regulations.
3. Lead Assessor ISO 13485 certification (advantageous).
4. Familiarity with drug-coated products or specialty devices.
Why Join This Medical Device Manufacturer?
This is an excellent opportunity to work with a global leader in medical technology. You will have the chance to shape the future of medical devices while being part of a collaborative, innovative team. The company offers professional development opportunities in an environment where your contributions truly make an impact.
Apply now to express your interest in a call to discuss the position further.
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