Supplier Quality Engineer

Katalyst CRO; Murrysville (Westmoreland County); On-site; USD 110,000 - 160,000; Full time

Job summary

Katalyst CRO is seeking an experienced Supplier Quality Engineer to support Philips Sleep & Respiratory Care manufacturing transfer activities. You will coordinate APQP activities, qualification of suppliers, and process validation while ensuring regulatory compliance across the transfer lifecycle.

The role requires hands-on expertise in PFMEA, Control Plans, MSA/SPC, and CAPA programs, with a focus on design and manufacturing transfers from source to receiving facilities.

Qualifications

• APQP/PPAP and PPAP/SPPA experience is required.
• Hands-on PFMEA, Control Plans, MSA and SPC.
• Strong CAPA, SCAR and root cause analysis knowledge.
• Experience with supplier qualification and audits in regulated industries.
• Experience with design and manufacturing transfer activities.

Responsibilities

• Partner with Development, Manufacturing, Procurement, and Suppliers to assess risks and define CTQ requirements.
• Lead APQP deliverables for supplier onboarding, product transfer, and change management activities.
• Review 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, 8D, and root cause methodologies.
• Support Design Transfer and Manufacturing Transfer activities from source manufacturing sites to receiving 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.

Skills

APQP & PPAP

PFMEA

Control Plans

MSA & SPC

CAPA & SCAR

Regulatory Knowledge

Cross-functional Collaboration

Supplier Quality Systems

Job description

Job Description

Support Philips Sleep & Respiratory Care manufacturing transfer activities through supplier qualification, APQP execution, process validation, supplier quality management, and sustaining production support.

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

• 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.

Requirements

• 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.

Preferred Experience

• Philips / Philips Respironics experience.
• Design Transfer or Manufacturing Transfer Lead experience within respiratory, ventilator, CPAP, or sleep therapy device companies.