Senior Supplier Quality Engineer

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

Job summary

Philips seeks a Senior Supplier Quality Engineer to oversee supplier quality, compliance, and process capability for the Colorado Springs site. You will lead MSA, PFMEA, Control Plans, SP C, PV&V and APQP/PPAP activities to ensure supplier readiness and regulatory compliance, collaborating with R&D, manufacturing and suppliers.

The role requires 5+ years in medical device SQE, knowledge of 21 CFR 803/806/820, ISO 13485 and ISO 14971, and strong cross-functional communication.

Qualifications

• Minimum 5+ years in Supplier Quality Engineering within FDA regulated medical device manufacturing/supplier environments.
• Experience with PFMEA, SPC, SCARs, SICRs, CAPA and APQP/PPAP activities.
• Knowledge of medical device regulations and standards (21 CFR Part 803/806/820, ISO 13485, ISO 14971).
• Strong data analytics skills to assess supplier performance and drive improvements.

Responsibilities

• Lead APQP/PPAP execution for supplier transfers, changes, and sustaining projects.
• Lead supplier audits and qualification activities, and manage SCAR investigations.
• Coordinate supplier corrective actions and verify effectiveness of fixes.
• Drive systemic supplier improvements using performance data and NC trends.

Skills

5+ years experience

APQP/PPAP

PFMEA

SPC

SICR/CAPA

Data analytics

Cross-functional influence

Regulatory knowledge

Education

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

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.

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.

• generous PTO
• 401k (up to 7% match)
• HSA (with company contribution)
• stock purchase plan
• education reimbursement
• much more

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% #LI-PH1

This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates.

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

At Philips, we believe that every human matters. As a global health-tech leader, we focus on improving people’s health and wellbeing through meaningful innovation. The people who work here share our passion and are motivated to bring this purpose to life. For more than 130 years, we have been creating technologies and innovations that improve people's lives and support healthcare practitioners. Headquartered in the Netherlands and operating in more than 100 countries globally, we focus our advanced technology and deep clinical and consumer insights on Precision Diagnosis, Image Guided Therapy, Enterprise Informatics, Monitoring/ Connected Care, Sleep & Respiratory Care and Personal Health. Together, we deliver better care for more people because we believe that every human matters. That's why we're taking steps to create an environment where we acknowledge and embrace our differences and uniqueness and listen to and value each other's views. When people feel cared for and listened to, they bring their best qualities to work, leading to better collaboration, communication, innovation and success.

It is the policy of Philips to provide equal employment and advancement opportunities to all qualified employees and applicants for employment without regard to race, color, religion, sex, pregnancy/childbirth or related medical conditions, age, ethnic or national origin, sexual orientation, gender identity or expression, physical or mental disability, genetic information, citizenship status, veteran or military status, marital or domestic partner status or any other characteristic protected by law.

To ensure reasonable accommodations for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974 and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance.

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