Philips is looking to solve the problem of driving supplier partners' high-quality performance and ensuring regulatory compliance in their Sleep & Respiratory Care Quality team.
Requirements
- Minimum of 5+ years’ experience in Supplier Quality 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.
- ASQ and/or Six Sigma DfX Certifications- Desired.
- Bachelor’s Degree (Required) in Quality, Engineering, or related disciplines.
- Experience with Design for Excellence (DfX) initiatives.
- Experience with Advanced Product Quality Planning (APQP)
Responsibilities
- Facilitates technical capability assessments of potential new suppliers, and collaboration between R&D and suppliers in Design for Excellence (DfX) initiatives to enhance product design quality and innovation.
- Conducts & reviews Design for Manufacturing and Assembly Technique (DFMAT), Supplier Approval Form (SAF), Measurement System Analysis (MSA), PFMEA, Control Plans, SPC, Process V&V, FAI, Logistics Risk Assessment (LRA), and Supplier Initiated Change Request (SICR).
- Develops, executes, monitors, and controls APQP (Advanced Product Quality Planning) plans as part of the NPI process to ensure consistent product quality.
- Focuses that Critical to Quality (CtQ) 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.
Other
- Minimum of a Bachelor’s Degree (Required) in Quality, Engineering, or related disciplines.
- 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.
- US work authorization is a precondition of employment.
- Company relocation benefits will not be provided for this position.
- This role may require travel up to 10%.
