Senior Supplier Quality Engineer - Marlborough, MA

IPG Medical Corporation is focused on developing next-generation medical products based on its state-of-the-art technology. Headquartered in Marlborough, MA, we aspire to work together with our employees and customers to apply light in ways that improve life.

Our mission is to develop innovative medical device laser solutions that make the world a better place. To accomplish this mission, we are committed to attracting and retaining the best talent and an engaged, diverse, and thriving workforce that drives a sustainable future for our company and society.

Working at IPG Medical Group you can expect challenging projects, a motivating and friendly environment, and competitive benefits.

SUMMARY OF PRIMARY DUTIES AND RESPONSIBILITIES:

Responsible for ensuring suppliers provide high quality materials and/or services that conform to the product quality and regulatory requirements. Key team member providing expertise on the capability of our suppliers, in establishing and maintaining the technical activities of our suppliers, and ensuring they meet business needs.

RESPONSIBILITIES:

• Participate on the core team for development projects and transfer to manufacturing with internal or external manufacturing facilities.
• Utilize risk-based approach in the classification and management of suppliers.
• Manage supplier issues arising at incoming inspection or on manufacturing floor.
• Resolution of quality issues including supplier non-conformances, corrective action requests, and CAPA.
• Lead the qualification of new suppliers, including supplier selection and approval.
• Responsible for coordinating initial component quality requirements, including first article inspection, process qualification, and assisting in supplier validation activities such as writing/approving protocols.
• Provide insight regarding supplier capabilities for new and existing products, in collaboration with manufacturing, engineering, R&D, and marketing.
• Conduct external supplier audits to ensure compliance. Independently manage resolution of quality issues observed during audit process to raise level of supplier performance.
• Execute and enforce Supplier and/or Distributor Quality Agreements.
• Maintain supplier quality records in accordance with FDA/GMP and EU MDR requirements.
• Lead the review of supplier change requests with cross-functional team, including evaluation of change, implementation planning, and approval.
• Generate KPI's and supplier metrics, including producing quarterly scorecards for supply base as defined.
• Ability to identify under-performing suppliers and work with them to improve or reduce defect occurrence rates, initiating transfer activities to alternative suppliers if necessary.
• Consolidation of supply base through identification of redundant capabilities and initiating/supporting manufacturing or service transfers as needed.
• Initiate and drive process/yield improvement projects where possible.
• Develop and support requirements and activities for "dock-to-stock" program.
• Ability to work independently, managing all requirements of supplier management program. Where possible, propose and implement continuous improvements for responsible areas.
• Mentor and develop quality personnel and/or organizational partners.
• Support contract manufacturers on quality issues resolution and change requests.

• 8+ years of experience
• Working experience in a medical device or life sciences industry.
• Strong written/verbal communication skills and demonstrated use of quality tools/methodologies.
• Working knowledgeable of design control requirements and manufacturing design tranfer process
• Working knowledge of FDA/QSR, ISO/EU MDR standards, process validation, product design control, CAPA/SCAR, and FMEA methodologies.
• Proficient with Microsoft Office applications.
• Certified Internal Auditor and/or experience performing Internal Audits strongly preferred.
• Current ASQ and/or six sigma certifications preferred.

EDUCATIONAL REQUIREMENTS:

• Bachelor of Science degree in a technical discipline

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