Supplier Quality Engineer

Philips•Colorado Springs, CO

24d•$63,000 - $100,000•Onsite

About The Position

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.

Requirements

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.
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).
Proven 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 (Required) in Quality, Engineering, or related disciplines.
US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.
Must reside in or within commuting distance to Colorado Springs, CO.

Nice To Haves

ASQ and/or Six Sigma DfX Certifications

Responsibilities

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.