Supplier Quality Engineer

Philips•Bedford, MA

3d•Hybrid

About The Position

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.

Requirements

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.
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).
Proven experience utilizing data analytics/KPI’s to assess supplier performance and identify/drive process improvement opportunities.
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.
Minimum of a Bachelor’s Degree (Required) in Quality, Engineering, or related disciplines.
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.
For this position, you must reside in or within commuting distance to Bedford, MA.

Nice To Haves

ASQ and/or Six Sigma DfX Certifications

Responsibilities

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.
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.