Supplier Quality Engineer
$63,000–$100,000 year
On-siteColorado Springs, Colorado, United States
Job Summary
Execute MSA, PFMEA, Control Plan, SPC, PV&V, FAI, and SICR activities within APQP/PPAP processes for the Image Guided Therapies - Devices business. Conduct supplier audits for initial qualification and for-cause assessments to verify compliance with quality systems and regulatory expectations. Qualify new suppliers for the Approved Supplier List by evaluating capability, maturity, and technical readiness. Support investigation and disposition of non-conformances, including defect analysis, containment, and root cause determination. Initiate, coordinate, and monitor Supplier Corrective Action Requests (SCAR) to ensure effective implementation and closure. This office-based role in Colorado Springs, CO, requires travel up to 10% and resides in the 3-day in-person work model.
Required Qualifications
- 1+ years' experience in Supplier Quality/Quality Engineering within highly regulated product environments
- focus on supplier selection, performance assessment, APQP, Risk Assessments/PFMEA's, SPC, SCAR's, SICR, CAPA, Remediation
- knowledge of medical device regulations, QMS requirements, and standards, such as 21 CFR Parts 803, 806, and 820, ISO 13485, ISO 14971, European Medical Device Directive (93/42/EEC), EU Medical Device Regulation, Canadian Medical Devices Regulation (SOR/98-282)
- experience utilizing data analytics/KPI's to assess supplier performance and identify/drive process improvement opportunities
- strong communication/collaboration skills and the proven ability to effectively communicate, influence and build relationships cross-functionally with a variety of internal/external stakeholders, suppliers, Regulatory Agencies, Notified Bodies etc.
- minimum of a Bachelor's Degree in Quality, Engineering, or related disciplines
- ability to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation
- US work authorization
- reside in or within commuting distance to Colorado Springs, CO
- travel up to 10%
Desired Qualifications
- Medical Device preferred
- ASQ and/or Six Sigma DfX Certifications
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