Supplier Quality Engineer - Medical Devices & PPAP Expert

Philips; Colorado Springs (CO); On-site; USD 63,000 - 100,000; Full time

Benefits offered by this job

Total Rewards benefits

PTO

401k with company match

HSA

Stock purchase plan

Education reimbursement

Job summary

Philips seeks a Supplier Quality Engineer to manage APQP/PPAP activities, supplier audits, and approvals. You will drive quality initiatives, perform PFMEA, SPC, and MSA analyses, and coordinate supplier development and CAPA activities within a regulated medical device environment.

Office-based role in a highly collaborative team, with travel up to 10% and a focus on robust supplier performance and continuous improvement.

Qualifications

• You have relevant experience with APQP/PPAP processes and quality planning activities.
• You understand quality system requirements and medical device regulations.
• You have hands-on experience with PFMEA, SPC, and CAPA programs.

Responsibilities

• Executes MSA, PFMEA, Control Plan, SPC, PV&V, FAI as part of APQP/PPAP and SICR.
• 2 Supports PPAP/APQP deliverables including IQ/OQ/PQ or process validation at suppliers.
• 3 Guides supplier improvement to enhance their quality processes for compliance.
• 4 Conducts supplier audits to assess compliance with QMS, regs, and supplier obligations.
• 5 Qualifies new suppliers for the Approved Supplier List with capability assessments.
• 6 Supports investigation and disposition of supplier non-conformances and containment actions.
• 7 Initiates and tracks SCAR, ensuring root cause, corrective actions and closure.

Skills

APQP/PPAP

PFMEA

Control Plan

SPC

MSA

FAI

SICR

SCAR

CAPA

Data analytics

Education

Associate's Degree

Bachelor's Degree

ASQ/Six Sigma DfX Certifications

Job description

Philips seeks a Supplier Quality Engineer to manage APQP/PPAP activities, supplier audits, and approvals. You will drive quality initiatives, perform PFMEA, SPC, and MSA analyses, and coordinate supplier development and CAPA activities within a regulated medical device environment.

Office-based role in a highly collaborative team, with travel up to 10% and a focus on robust supplier performance and continuous improvement.