Job Title: Supplier Quality Engineer III
We are seeking a highly skilled Supplier Quality Engineer III to join our team in Galway, Ireland.
The Role:
As the Supplier Quality Engineer, you will collaborate with cross-functional teams and suppliers to address quality concerns for PI divisional products, enhancing supplier performance and ensuring consistency with standards.
This role offers opportunities to participate in global supplier quality management projects, with some travel required to engage with suppliers effectively.
Responsibilities:
* Manage quality performance of sourced finished medical device manufacturers (OEM and Contract Manufacturers).
* Evaluate and communicate quality issues to suppliers, applying sound problem-solving methodologies to identify, assess, prioritize, and resolve quality issues.
* Investigate and solve non-conformances due to incoming inspection at distribution centers.
* Support investigation of material quality issues/complaints, ensuring adequate corrective actions are identified, implemented, and controlled by suppliers.
* Review and approve supplier corrective action plans and verification of effectiveness documentation through SCAR ownership.
* Plan and lead supplier assessments to ensure compliance with regulatory standards and Boston Scientific requirements.
* Collaborate with Supplier Engineering and Commercial Sourcing for multiple aspects of supplier management, supporting quality, cost, and service objectives.
* Sustain quality issues, process change impacts, and design change implementations for suppliers within their quality system.
Requirements:
* A Level 8 degree in an engineering or technical discipline.
* At least 4 years of related work experience in the regulated industry, including understanding of QSR and ISO standard requirements.
* Ability to work independently, organized, and self-driven.
* A strong communicator who can present data/information to all stakeholders.
* Competency in Microsoft software systems (e.g., MS Excel, PowerPoint, Power BI) and QMS software systems (CAPA, SCAR, etc.).
* Domestic and international travel up to 25%.
Preferred Qualifications:
* Prior experience within a quality function, preferably supplier quality.
* Knowledge of medical device regulations and quality system requirements.
* Lead Assessor ISO13485 certification preferred.
* Familiarity with drug-coated products advantageous.
Please note that this is a confidential discussion opportunity. We look forward to speaking with qualified candidates.