Supplier Quality Engineer

Regulatory Jobs; Bedford (MA); On-site; USD 103,000 - 163,000; Full time

Job summary

Philips is seeking a Senior Supplier Quality Engineer to join the Image Guided Therapy Devices (IGTD) Quality team in Bedford, MA. The role drives supplier performance, APQP and process validation while ensuring regulatory compliance across the product lifecycle.

You will oversee supplier audits, NC/SCAR management, data-driven quality improvements, and interface with Regulatory Agencies and Notified Bodies.

Qualifications

• 5+ years in Supplier Quality Engineering within FDA-regulated medical device environments (supplier selection, performance assessment, APQP, Risk Assessments/PFMEA, SPC, SCAR, SICR, CAPA, Remediation).
• Knowledge of medical device regulations and standards: 21 CFR Parts 803/806/820, ISO 13485, ISO 14971, EU MDR, EU Medical Device Regulation, Canadian MDR.
• Ability to analyze data/KPIs to drive process improvements and assess supplier performance; strong cross-functional communication skills.
• Bachelor’s Degree in Quality/Engineering or related field is required; ASQ Six Sigma (DFx) certifications are desirable.

Responsibilities

• Coordinate and drive supplier improvement initiatives and manage Approved Supplier List; negotiate Supplier Quality Agreements.
• Provide sustaining SQE activities handling NCRs/SCARs/SCNs and ASL; manage APQP with suppliers.
• Facilitate supplier capability assessments and supplier selection; monitor quality performance trends.
• Lead end-to-end performance management of suppliers; determine supplier-caused defects; act as reviewer for Supplier Corrective Actions (SCARs).
• Develop and oversee equipment qualification and process validation plans; lead continuous improvement projects based on trends and regulatory needs.
• Provide Quality oversight of supplier change requests with regulatory validation; audit planning, execution, reporting and closure.

Skills

Supplier Quality Eng

APQP

PFMEA

SPC

SCAR

CAPA

Data analytics

Cross-functional comms

Regulatory knowledge

Education

Bachelor's Degree in Quality/Engineering

Tools

ASQ Six Sigma

Job description

Job Title

Senior Supplier Quality Engineer

Job Description

The Senior 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 (5 days per week) in the company’s facility. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations. This is an ON‑SITE 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.

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