Supplier Quality Engineer

Supplier Quality Engineer Job Description

The Supplier Quality Engineer supports supplier qualification, supplier audits, Approved Supplier List onboarding, APQP / PPAP execution, process validation, and supplier improvement initiatives within the Image Guided Therapies - Devices business.

• Executes MSA (Measurement System Analysis), PFMEA (Process Failure Mode and Effects Analysis), Control Plan, SPC (Statistical Process Control), PV&V (Process Validation and Verification), FAI (First Article Inspection), as part of APQP (Advanced Product Quality Planning) / PPAP activities and SICR (Supplier Initiated Change Request).
• Supports PPAP/ APQP (Advanced Product Quality Planning) processes/deliverables including IQ/OQ/PQ or process validation activities at the supplier.
• Supports supplier improvement and development on APQP, providing guidance and resources to help suppliers enhance their quality processes and achieve compliance.
• Conducts supplier audits, including initial qualification and for-cause, to assess supplier compliance with applicable quality system requirements, regulatory expectations, process controls, and supplier agreement obligations.
• Qualifies new suppliers for addition to the Approved Supplier List, including assessment of supplier capability, quality system maturity, technical readiness, risk classification, approval documentation, and completion of required onboarding activities.
• Supports investigation and disposition of supplier-related non-conformances, including defect analysis, supplier-cause determination, containment, risk assessment, and escalation as needed.
• Initiates, coordinates, and monitors Supplier Corrective Action Requests (SCAR), ensuring effective root cause analysis, corrective/preventive action implementation, verification of effectiveness, and timely closure.

• You have a minimum of 1+ years’ experience in Supplier Quality/Quality Engineering within highly regulated product environments (Medical Device preferred), with a focus on supplier selection, performance assessment, APQP, Risk Assessments/PFMEA’s, SPC, SCAR’s, SICR, CAPA, Remediation etc.
• You have 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).
• You have proven experience utilizing data analytics/KPI’s to assess supplier performance and identify/drive process improvement opportunities.
• You have 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.
• You have a minimum of a Bachelor’s Degree (Required) in Quality, Engineering, or related disciplines. ASQ and/or Six Sigma DfX Certifications
  - Desired.
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.

We believe that we are better together than a part. For our Office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations. This is an Office role.

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody, everywhere, has access to the quality of healthcare that we all deserve. Do the work of your life to help improve the lives of others.

• Learn more about our business.
• Discover our rich and exciting history.
• Learn more about our purpose.
• Learn more about our culture.

• The pay range for this position in Colorado Springs, CO is $63,000 to $100,000

The actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills,…