Executes cross-functional collaboration & communication: Work closely with internal stakeholders and support suppliers in meeting quality and regulatory requirements by actively applying skills from the Quality Body-of-Knowledge for supplier controls related to components and materials used in medical devices, drug/device combination products, other regulated products, and purchased finished goods.
Supports compliance: Identify improvement opportunities to proactively ensure vendor compliance with all applicable internal, domestic, and international quality regulations, including but not limited to US 21 CFR 210, 211, and 820, ISO 13485, ISO 14971, EU MDR, etc.
Leads issue resolution & continuous improvement: Collaborate and partner closely with our suppliers to reduce risk, improve processes, and reduce waste using quality improvement tools of process control & monitoring, DOE, risk analysis, problem solving processes, protocol development, trend analysis and reaction, capability analysis and measurement system analysis.
Performs supplier qualifications and assessments: Assess new suppliers for suitability and regularly reassess existing suppliers to ensure ongoing compliance and consistent performance through Supplier Qualifications, Supplier Quality Agreements, Supplier Corrective Action Requests (SCARs), Supplier Change Notice evaluations, Supplier Scorecards, and Internal & External Audit Support.

Bachelor’s Degree or higher (completed and verified prior to start)
Three (3) years of Quality, Continuous Improvement, or Operations/Supply Chain functions in the Medical Device/Pharmaceutical/Aerospace industry in a private, public, government or military environment
ASQ Certified Supplier Quality Professional (CSQP) or Certified Quality Engineer (CQE) desired
Demonstrated experience with quality management systems or regulatory requirements (ISO 13485, ISO 9001, CRF Part 820, MDSAP)
Influential in areas including, but not limited to, compliance excellence, continuous improvement, product-related risk mitigation, and/or manufacturing process capability enhancement
Strong analytical, root-cause analysis, and problem-solving skills
Ability to work independently and manage multiple projects simultaneously
Proficiency in Microsoft Office Suite and quality management software
Keen attention to detail, with the ability to identify small issues that could escalate into larger problems if left unaddressed.

Senior Supplier Quality Engineer

Key skills