Senior Supplier Engineer

Philips•Reedsville, PA

9d•$92,000 - $146,000•Onsite

About The Position

The Senior Supplier Engineer is a key member of Philips’ Ultrasound Imaging Quality team, responsible for driving supplier performance and continuous/process improvement by applying Advanced Product Quality Planning (APQP) processes, striving for continuous quality improvement throughout the product lifecycle, and ensuring regulatory compliance.

Requirements

Minimum of 5+ years’ experience in Supplier Engineering within highly regulated product environments (Medical Device preferred), 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 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.
Must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.

Nice To Haves

ASQ and/or Six Sigma DfX Certifications

Responsibilities

Facilitates technical capability assessments of potential new suppliers, ensuring they meet the company's quality standards, and contributes to the supplier selection.
Conducts & reviews DFMAT (Design for Manufacturing and Assembly Technique), SAF (Supplier Approval Form), MSA (Measurement System Analysis), PFMEA (Process Failure Mode and Effects Analysis), Control Plan, SPC (Statistical Process Control), PV&V (Process Validation and Verification), FAI (First Article Inspection), LRA (Logistics Risk Assessment), and SICR (Supplier Initiated Change Request).
Develops, executes, monitors, and controls APQP (Advanced Product Quality Planning) plans as part of the NPI process to ensure consistent product quality.
Contributes to the content of the Supplier Project Book, documenting detailed quality requirements and expectations for suppliers.
Facilitates collaboration between R&D and suppliers in Design for Excellence (DfX) initiatives to enhance product design quality and innovation.
Focuses that Critical to Safety/Quality (CtS/Q) characteristics are effectively communicated to suppliers and rigorously maintained throughout the production process.
Coordinates Part Submission Warrant plans, deliverables, line releases, and completion, ensuring all parts meet specified quality standards before approval.
Executes supplier improvement and development initiatives on APQP (Advanced Product Quality Planning), providing guidance and resources to enhance supplier processes, ensuring they meet the high standards required for production quality and efficiency.
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.