Supplier Quality Engineer (Mid-Level) – Medical Device Manufacturer, County Galway, Ireland

About the Role:

A fantastic opportunity has arisen for an experienced Supplier Quality Engineer to join a global medical device manufacturer based in County Galway, Ireland. This pivotal role involves overseeing the quality performance of externally sourced finished medical devices, working with both OEM and Contract Manufacturers. The role provides an exciting opportunity to work with cutting-edge medical technology while collaborating with a global network of suppliers and cross-functional teams to enhance product quality.

As a Supplier Quality Engineer, you will play a vital role in resolving quality issues, implementing corrective actions, and ensuring that suppliers meet high standards for quality, cost, and service. With a focus on driving continuous improvement and developing supplier capabilities, you will have the opportunity to make a lasting impact on the quality of medical devices and improve patient outcomes worldwide.

Key Responsibilities:

• Supplier Quality Management: Oversee the quality performance of externally manufactured medical devices, ensuring compliance with regulatory standards and the company’s quality expectations.

• Quality Issue Resolution: Evaluate and resolve quality issues related to incoming inspections at distribution centres, and effectively communicate solutions to suppliers.

• Corrective Actions & CAPA: Work with suppliers to implement robust Corrective Actions for non-conformance issues, ensuring that all actions are properly documented and verified for effectiveness.

• Supplier Audits & Assessments: Lead supplier assessments to ensure compliance with both regulatory standards and the company’s quality requirements. Provide guidance and support to improve supplier performance.

• Cross-Functional Collaboration: Partner with Supplier Engineering and Commercial Sourcing teams to meet quality, cost, and service objectives. Lead the integration of suppliers into New Product Development (NPD) projects, ensuring quality deliverables.

• Sustaining Quality & Process Changes: Support sustaining quality issues and design or process changes, collaborating with suppliers to ensure all changes are successfully implemented.

• Travel Requirements: This position involves occasional domestic and international travel (up to 25%) to visit suppliers and support quality-related activities.

Required Qualifications:

• Degree (Level 8) in Engineering or a related technical discipline.

• 4+ years of experience within a regulated industry, ideally within medical device quality management, with a strong understanding of QSR (Quality System Regulations) and ISO standards.

• Proficiency with Microsoft Office (Excel, PowerPoint, Power BI) and Quality Management Systems (QMS), particularly CAPA and SCAR.

• Excellent communication skills (written and verbal), with the ability to present data and collaborate with cross-functional teams and external stakeholders.

• Ability to work independently, prioritise tasks, and drive quality improvement initiatives.

Preferred Qualifications:

• Experience within supplier quality management in the medical device sector.

• Knowledge of ISO 13485 and medical device regulations.

• Lead Assessor ISO 13485 certification is highly advantageous.

• Familiarity with drug-coated products or specialty devices is a plus.

Why Join a Global Medical Device Manufacturer?

This is a fantastic opportunity to work with one of the world’s leading medical technology companies. You’ll be part of a dynamic and innovative team where your expertise will contribute to improving patient lives globally. With a supportive work environment and opportunities for professional growth, this role provides you the chance to make a real impact in the medical device industry.

Community & Quality of Life in County Galway:

County Galway, Ireland, offers a rich cultural heritage, stunning natural landscapes, and a vibrant community, making it an ideal place to live and work. The quality of life is excellent, with a perfect balance of rural tranquillity and access to bustling city amenities, all while living in one of Ireland's most beautiful regions.

If you are a driven, detail-oriented individual with a passion for quality improvement in the medical device industry, apply now for the Supplier Quality Engineer position. Take the next step in your career and join a leading global medical technology company committed to innovation and improving patient care.

“Our Vision: To be recognised as the best STEM Contracting & Permanent Recruitment company and the Employer of Choice for top performing Recruiters 

 For further information on this role please contact Lisa Lawlor on 0868395533 or email stem@hero.ie 

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

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