Supplier Quality Engineer

## Supplier Quality Engineer Apply locations:
Colorado Springs, Colorado, United Statestime type:
Full time posted on:
Posted Todayjob requisition :
589894### Job Title 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.  
** Your role:*
* * 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're the right fit if:*
* * 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 Associate's Degree (Required). Bachelor's Degree and/or ASQ/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****.*
* ** How we work together:
** 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 (5 days per week)
*** 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 ON-SITE role.*
* ** About…