Our client, a major multinational based here in Galway, is seeking a Supplier Quality Engineer III to join their team.
The Role:
As the Supplier Quality Engineer, you will collaborate with cross-functional teams and suppliers to address quality concerns for PI divisional products, playing a key role in enhancing supplier performance and strengthening their ability to consistently meet standards.
This position offers the opportunity to participate in supplier-related projects across the global supplier quality management network. Some travel will be required to support and engage with suppliers effectively.
Responsibilities:
1. Responsible for quality performance of sourced finished medical device manufacturers (OEM and Contract Manufacturers).
2. Evaluate and communicate quality issues to suppliers and apply sound, systematic problem-solving methodologies in identifying, risk assessing, prioritizing, and resolving quality issues.
3. Investigate and solve non-conformances due to incoming inspection at distribution centers.
4. Support investigation of material quality issues/complaints as they arise and ensure that adequate corrective actions are identified, implemented, and controlled by suppliers.
5. Review and approve supplier corrective action plans and verification of effectiveness documentation through SCAR ownership.
6. Plan and lead supplier assessments to assess compliance with regulatory standards and Boston Scientific requirements.
7. Act as a technical team member partnering with Supplier Engineering and Commercial Sourcing for multiple aspects of supplier management supporting objectives of the team in terms of quality, cost, and service including supplier originated changes, design, and labeling changes.
8. Support sustaining quality issues, process change impacts, and design change implementations for suppliers within their quality system, and in the quality system.
9. Team member of New Product Development (NPD) projects with responsibilities for execution of applicable SFMD Plan deliverables and collaboration with cross-functional new product development teams to onboard finished medical device suppliers.
Requirements:
1. Level 8 degree in an engineering or technical discipline.
2. 4+ years of related work experience in the regulated industry including demonstrated understanding of QSR and ISO standard requirements for material/purchasing controls, product realization, validation, and CAPA.
3. Ability to work independently; organized and self-driven.
4. A strong communicator (written and verbal) who can effectively organize, present, and explain data/information with all internal & external stakeholders.
5. Competency in Microsoft software systems e.g. MS Excel, PowerPoint, Power BI and in QMS software systems (CAPA, SCAR, etc.).
6. Domestic and international travel up to 25%.
Preferred Qualifications:
1. Prior experience within a quality function, preferably supplier quality.
2. Knowledge of medical device regulations, specifically material controls quality system requirements.
3. Lead Assessor ISO13485 certification preferred.
4. Familiarity with drug-coated products advantageous.
For more information and a confidential discussion on the role, please contact Michelle Mc Inerney.
michelle.mcinerney@collinsmcnicholas.ie
091 706717
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