Senior Supplier Quality Engineer

Philips; Bedford (MA); Presencial; USD 103.000 - 163.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

PTO (paid time off)

401k with match

HSA with company contribution

Stock purchase plan

Education reimbursement

Descripción de la vacante

Philips in Bedford, MA seeks a Senior Supplier Quality Engineer to drive supplier performance and quality improvement across the product lifecycle in FDA-regulated medical devices. You will coordinate improvement initiatives, manage the ASL, and negotiate supplier quality agreements while leading audits and CAPA activities.

You will apply APQP, PFMEA, SPC and data analytics to assess supplier performance, determine root causes, and implement preventive actions.

Formación

• 5+ years in Supplier Quality Engineering within FDA regulated medical devices.
• Experience with supplier selection, APQP, PFMEA, SPC, SCARs and CAPA.
• Knowledge of 21 CFR Parts 803/806/820, ISO 13485, ISO 14971, EU MDR/EC, Canadian MDR.
• Ability to analyze supplier performance using KPI data and drive improvements.
• Strong communication and cross-functional collaboration skills.

Responsabilidades

• Coordinate and execute supplier improvement initiatives; manage ASL and negotiate SQ agreements.
• Provide sustaining SQE activities for NCRs, SCARs, SCNs and ASL maintenance.
• Manage APQP with selected suppliers and conduct capability assessments.
• Lead trend analysis of product/process quality and troubleshoot issues.
• Oversee supplier qualification, change requests review and regulatory validation.
• Drive SCARs and preventive actions; act as internal and supplier auditor.
• Develop qualification and validation plans; lead improvement projects based on data.

Conocimientos

Supplier quality

APQP

Risk PFMEA

SCAR/SCN/CAPA

Data analytics

Cross-functional comms

Educación

Bachelor's degree in Quality/Engineering

Herramientas

SPC

Descripción del empleo

Senior Supplier Quality Engineer# Careers## Senior Supplier Quality EngineerApply: Bedford, Massachusetts, United States: Full time: Posted Today: 585656### Job TitleSenior Supplier Quality Engineer### Job DescriptionThe 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%. ***#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. Interested candidates are encouraged to apply as soon as possible to ensure consideration.*Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace.*