Senior Supplier Quality Engineer

Regulatory Toolkit; Colorado Springs (CO); On-site; USD 92,000 - 146,000; Full time

Job summary

Philips in Colorado Springs is seeking a Senior Supplier Quality Engineer to own supplier quality, compliance, and process capability across sustaining activities for the Image Guided Therapy Devices portfolio.

You will lead APQP/PPAP, PFMEA, SPC, SCAR/CAPA, supplier audits and qualification, coordinating with R&D, Manufacturing and suppliers to ensure robust designs, qualification readiness, and ongoing quality improvements.

Qualifications

• Minimum 5+ years of experience in Supplier Quality Engineering in FDA-regulated medical device manufacturing environments.
• Experience in supplier selection, performance assessment, PFMEA, SPC, SCAR, SICR, CAPA, and APQP/PPAP activities.
• Knowledge of medical device regulations and standards (21 CFR Parts 803, 806, 820; ISO 13485, ISO 14971; EU MDR; Canadian MDR).
• Strong data analytics and ability to drive supplier process improvements; excellent cross-functional communication.

Responsibilities

• Serve as the primary Supplier Quality Engineering contact for the Colorado Springs site.
• Lead APQP/PPAP, PFMEA, Control Plan, SPC, PV&V, FAI, IQ/OQ/PQ and related activities.
• Coordinate supplier qualification and onboarding for new suppliers and changes.
• Lead supplier audits and non-conformance investigations; drive CAPA and corrective actions.
• Drive supplier performance improvement using metrics and SCAR history.
• Collaborate with R&D, Manufacturing, and suppliers to improve design quality and manufacturability.

Skills

Supplier Quality Engineering

Data analytics

Cross-functional communication

Regulatory knowledge

APQP/PPAP

PFMEA

SPC

CAPA

SICR

Supplier audits

Education

Bachelor's degree in Mechanical, Electrical, Biomedical, or Industrial Engineering

ASQ Six Sigma DfX (Desirable)

Job description

Job Title

Senior Supplier Quality Engineer

Job Description

The Senior Supplier Quality Engineer ensures supplier quality, compliance, and process capability across sustaining activities within Philips’ Image Guided Therapy Devices business.

Your role:

• Serves as the primary Supplier Quality Engineering point of contact for the Colorado Springs, CO facility, providing on-site support ensuring timely alignment with site Quality, Manufacturing, R&D, Sustaining Engineering, Procurement, and supplier stakeholders.
• Leads and owns MSA, PFMEA, Control Plan, SPC, PV&V, FAI, IQ/OQ/PQ, and related APQP / PPAP activities to ensure supplier process capability, validation readiness, and compliance with quality requirements.
• Leads APQP / PPAP execution for supplier transfers, supplier changes, SICRs, and sustaining projects supporting the Fremont, CA manufacturing facility.
• Facilitates Design for Excellence collaboration between R&D, Sustaining Engineering, Manufacturing, and suppliers to improve design quality, manufacturability, supplier process robustness, and long-term product performance.
• Ensures Critical to Quality characteristics are clearly defined, flowed down to suppliers, validated through appropriate controls, and maintained throughout production.
• Leads supplier audits, including initial qualification, for-cause, and follow-up audits, to assess supplier compliance with applicable quality system requirements, regulatory expectations, process controls, and supplier agreement obligations.
• Leads supplier qualification activities for addition to the Approved Supplier List, including supplier capability assessment, quality system maturity evaluation, technical readiness, risk classification, approval documentation, and onboarding completion.
• Leads supplier-related non-conformance investigations, including defect analysis, supplier-cause determination, containment, risk assessment, escalation, and disposition support.
• Initiates, coordinates, and manages Supplier Corrective Action Requests, ensuring effective root cause analysis, corrective/preventive action implementation, verification of effectiveness, and timely closure.
• Drives systemic supplier improvement using supplier performance data, NC trends, audit outcomes, SCAR history, defect recurrence, and process capability indicators.

You're the right fit if:

• You have a minimum of 5+ years' experience in Supplier Quality Engineering within FDA regulated medical device (Class II & III) manufacturing/supplier environments.

• You have strong experience in supplier selection, performance assessment, Risk Assessments/PFMEA’s, SPC, SCAR’s, SICR, CAPA, and related APQP/PPAP activities.

• You have detailed knowledge of medical device regulations, 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 communications skills and the proven ability to effectively influence and build relationships cross-functionally with a variety of internal/external stakeholders, suppliers, Regulatory Agencies, Notified Bodies etc.
• You have a Bachelors Degree in Mechanical, Electrical, Biomedical, or Industrial Engineering, or related technical discipline. 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.

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 Onsite role.

About Philips:

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.

Philips Transparency Details:

• The pay range for this position in Colorado Springs, CO is $92,000 to $146,000.

At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case.

The actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity.

In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered. Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more. Details about our benefits can be found here.

Additional Information:

• 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.
• Company relocation benefits will not be provided for this position. For this position, you must reside in or within commuting distance to Colorado Springs, CO.
• This role may require travel up to 10%

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Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace.