Supplier Engineer-Ultrasound

Supplier Engineer – Ultrasound

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.

• Facilitates technical capability assessments of potential new suppliers, ensuring they meet the company's quality standards, and contributes to the supplier selection.
• Conducts and reviews DFMAT, SAF, MSA, PFMEA, Control Plan, SPC, PV&V, FAI, LRA, and SICR.
• Develops, executes, monitors, and controls APQP 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 initiatives to enhance product design quality and innovation.
• Focuses that Critical to Safety/Quality 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, 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.

• You have a minimum of 3+ 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.
• 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 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.

• Office-based: in-person at least 3 days per week, full-time presence in company’s facilities. This is an Office role.
• Travel may be required up to 10%.
• You must reside in or within commuting distance of Reedsville, PA. Company relocation benefits will not be provided.
• US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.

The pay range for this position in Reedsville, PA is $92,000 to $146,000.

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