Supplier Quality Engineer

Philips International; Tennessee; On-site; USD 103,000 - 163,000; Full time

Benefits offered by this job

PTO

401k match

HSA with company contribution

Stock purchase plan

Education reimbursement

Job summary

Philips is seeking a Supplier Quality Engineer to drive supplier performance, APQP, and regulatory compliance within the Image Guided Therapy Devices Quality team. The role covers supplier qualification, NCR/SCAR management, data-driven improvement, and audit leadership to ensure high-quality outputs across the supplier base.

You will coordinate supplier assessments, monitor trends, and support end-to-end supplier performance management, with a focus on FDA-regulated medical devices and global

Qualifications

• Minimum 5+ years in Supplier Quality Engineering within FDA-regulated medical-device environments.
• Experience with supplier selection, performance assessment, APQP, PFMEA, SPC, SCARs, CAPA, remediation.

Responsibilities

• Coordinate and execute supplier improvement initiatives and manage APQP with selected suppliers.
• Lead daily NCRs/SCARs/SCNs and ASL management; act as internal and supplier auditor.
• Develop equipment qualification and process validation plans; lead CI projects based on trends.
• Drive supplier improvement and corrective actions (SCARs, CAPA) across the supply base.
• Oversee regulatory review and validation for supplier change requests.

Skills

Supplier quality

APQP

Risk assessments/PFMEA

SCAR/CAPA

SICR

Data analytics/KPIs

Cross-functional communication

Education

Bachelor’s degree in Quality/Engineering

Job description

Job Title Supplier Quality Engineer Job Description The Supplier Quality Engineer is a key member of Philips’ Image Guided Therapy Devices (IGTD) Quality team, responsible for driving supplier performance and continuous/process improvement, striving for continuous quality improvement throughout the product lifecycle, and ensuring regulatory compliance.

Your role:

• Coordinates and executes supplier improvement initiatives, managing the Approved Supplier List and negotiating Supplier Quality Agreements.
• Provide sustaining SQE activities in managing daily NCR's, SCAR's, SCN's, and the ASL.
• Manage APQP with selected suppliers.
• Facilitates technical capability assessments of potential new suppliers, ensuring they meet the company's quality standards, and contributes to the supplier selection.
• Proactively monitoring and measuring product/process quality and performance trends and troubleshooting of production/release issues.
• Assists with the process of making additions, changes, or deletions to the Approved Supplier List, ensuring that only qualified suppliers are retained.
• Supports in end-to-end performance management of suppliers, conducts detailed analysis of defects to determine if they are supplier-caused, and acts as an independent reviewer for Supplier Corrective Action Requests.
• Proactively monitoring and measuring product/process quality and performance trends and troubleshooting of production/release issues.
• Develop and oversee equipment qualification and process validation plans and lead continuous improvement projects based on process/product trends, customer complaints, industry standards and government regulations.
• Provide Quality oversight of product/process change requests from suppliers, ensuring appropriate regulatory review and adequate validation to support requested changes.
• Drive supplier improvement, corrective and corrective actions (SCARS).
• Serve as internal and supplier quality auditor, managing planning, execution, reporting and closure of audits and audit findings.

You're the right fit if:

• You have a minimum of 5+ years’ experience in Supplier Quality Engineering within FDA regulated medical device environments, with a focus on supplier selection, performance assessment, APQP, Risk Assessments/PFMEA’s, SPC, SCAR’s, SICR, CAPA, Remediation etc.
• 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 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 Bachelor’s Degree (Required) in Quality, Engineering, or related disciplines.
• 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 (% 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 Office-based 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 Bedford, MA is $103,000 to $163,000
• 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. 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.
• 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 Bedford, MA.
• This role may require travel up to 10%.
• This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates.

Equal Employment and Opportunity

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

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

Know Your Rights

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 that acknowledges and embraces our differences and uniqueness and listens to and value each other's views. When people feel cared for and listened to, they bring their best qualities to work, leading to greater collaboration, 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.

As an equal opportunity employer, Philips is committed towards fostering a culture where all are treated with respect and professionalism.

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.