What are the responsibilities and job description for the Supplier Quality Engineer position at Katalyst CRO?
Job Description
Support Philips Sleep & Respiratory Care manufacturing transfer activities through supplier qualification, APQP execution, process validation, supplier quality management, and sustaining production support.
Responsibilities
Support Philips Sleep & Respiratory Care manufacturing transfer activities through supplier qualification, APQP execution, process validation, supplier quality management, and sustaining production support.
Responsibilities
- Partner with Development, Manufacturing, Procurement, and Suppliers to assess risks and define Critical-to-Quality (CTQ) requirements.
- Lead and execute APQP deliverables for supplier onboarding, product transfer, and change management activities.
- Review and support PFMEA, Control Plans, MSA, SPC, Process Validation, and Line Release activities.
- Support supplier qualification, supplier audits, supplier performance monitoring, and supplier corrective action programs.
- Drive disposition and resolution of supplier quality issues using CAPA, SCAR, Client, 8D, and root cause methodologies.
- Support Design Transfer and Manufacturing Transfer activities from source manufacturing sites to receiving manufacturing facilities.
- Coordinate IQ/OQ/PQ, TMV, validation builds, and process readiness activities.
- Work closely with cross-functional teams to ensure compliance with quality and regulatory requirements throughout the transfer lifecycle.
- Support New Product Introduction (NPI), sustaining engineering, and manufacturing change implementation.
- 5 years of Supplier Quality Engineering experience in Medical Devices or other regulated industries.
- Hands-on experience with APQP, PPAP/SPPA, PFMEA, Control Plans, MSA, SPC, and Process Validation.
- Strong knowledge of CAPA, SCAR, Client, Root Cause Analysis, and Supplier Quality Systems.
- Experience supporting Manufacturing Transfer, Design Transfer, or NPI programs.
- Working knowledge of ISO 13485 and FDA 21 CFR Part 820 requirements.
- Strong communication and stakeholder management skills.
- Philips / Philips Respironics experience.
- Design Transfer or Manufacturing Transfer Lead experience within respiratory, ventilator, CPAP, or sleep therapy device companies.