Company Overview: Our client is a leading innovator in medical device technology, specializing in advanced laser-powered solutions that enhance patient care. Committed to cutting-edge innovation and excellence, they push the boundaries of medical advancements to improve healthcare outcomes. Join a company where innovation meets purpose and helps shape the future of medical technology.
Position: The Senior Supplier Quality Engineer will ensure suppliers provide high-quality materials and/or services that conform to product quality and regulatory requirements. This critical role will provide expertise on supplier's capability to establish and maintain their technical activities and ensure they meet business needs.
RESPONSIBILITIES:
Participate on the core team for development projects and transfer to manufacturing with internal or external manufacturing facilities.
Utilize a risk-based approach in the classification and management of suppliers.
Manage supplier issues arising from incoming inspections or on the 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 and 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 resolve quality issues observed during the audit process to raise supplier performance.
Execute and enforce Supplier and/or Distributor Quality Agreements.
Maintain supplier quality records under FDA/GMP and EU MDR requirements.
Lead the review of supplier change requests with cross-functional teams, including change evaluation, implementation planning, and approval.
Generate KPIs and supplier metrics, including producing quarterly scorecards for the supply base as defined.
Ability to identify and work with underperforming suppliers to improve or reduce defect occurrence rates, initiating transfer activities to alternative suppliers if necessary.
Consolidate the supply base by identifying redundant capabilities and the initiation/support of 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 the 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.
Requirements:
Bachelor of Science degree in a technical discipline.
Working experience in a medical device or life sciences industry.
Strong written/verbal communication skills and demonstrated use of quality tools/methodologies.
Working knowledge of design control requirements and manufacturing design transfer process
Working knowledge of FDA/QSR, ISO/EU MDR standards, process validation, product design control, CAPA/SCAR, and FMEA methodologies.