Katalyst CRO
Overview
The
Senior Supplier Quality Engineer
role at
Katalyst CRO
supports External Manufacturing and Supplier Quality functions by executing both strategic and tactical quality activities. This includes base business support, nonconformance (NC) root cause investigations, and driving quality improvements to ensure compliance, reduce risk, and enhance efficiency. The role involves strong collaboration with suppliers and cross-functional teams (Procurement, Operations, R&D, Supply Chain, and NPI) to minimize supply chain risks while implementing innovative, measurable improvements. The ideal candidate will work with minimal supervision and bring deep knowledge of medical device regulations, GMP, and supplier quality systems. Responsibilities
Provide sound, risk-based QA direction and make timely decisions on complex quality and compliance issues. Conduct root cause analysis and failure investigations; approve and monitor supplier corrective actions. Ensure execution of Quality Management Systems (QMS) related to supplier selection, change control, qualification, NC/CAPA, quality agreements, and performance monitoring. Lead risk assessment and mitigation strategies for suppliers, including Quality Agreement creation and control plan assessments. Serve as a key liaison with suppliers, ensuring strong relationships and compliance with regulatory and company requirements. Perform tasks in compliance with safety policies, quality systems, and cGMP requirements. Take on additional duties as assigned with flexibility and adaptability. External Manufacturing & Supplier Quality. Medical Device Regulatory Compliance (FDA, ISO 13485, 21 CFR Part 820). Requirements
46 years in a regulated medical device or life sciences manufacturing environment. Strong background in Supplier Quality Engineering. Hands-on production line experience including validation activities. Expertise in NC/CAPA, FMEA, Design Control, and New Product Introduction (NPI). Prior experience with Pharmaceutical or similar organizations is preferred. Critical thinking, detail-oriented, strong verbal and written communication skills. Demonstrated ability to lead projects within a regulated environment. Supervisory or team leadership experience; ability to drive timelines and project deliverables. Proficiency in Excel (chart creation, scheduling, tracking). Program or project management skillset. Seniority level
Mid-Senior level Employment type
Contract Job function
Quality Assurance Industries
Pharmaceutical Manufacturing
#J-18808-Ljbffr
The
Senior Supplier Quality Engineer
role at
Katalyst CRO
supports External Manufacturing and Supplier Quality functions by executing both strategic and tactical quality activities. This includes base business support, nonconformance (NC) root cause investigations, and driving quality improvements to ensure compliance, reduce risk, and enhance efficiency. The role involves strong collaboration with suppliers and cross-functional teams (Procurement, Operations, R&D, Supply Chain, and NPI) to minimize supply chain risks while implementing innovative, measurable improvements. The ideal candidate will work with minimal supervision and bring deep knowledge of medical device regulations, GMP, and supplier quality systems. Responsibilities
Provide sound, risk-based QA direction and make timely decisions on complex quality and compliance issues. Conduct root cause analysis and failure investigations; approve and monitor supplier corrective actions. Ensure execution of Quality Management Systems (QMS) related to supplier selection, change control, qualification, NC/CAPA, quality agreements, and performance monitoring. Lead risk assessment and mitigation strategies for suppliers, including Quality Agreement creation and control plan assessments. Serve as a key liaison with suppliers, ensuring strong relationships and compliance with regulatory and company requirements. Perform tasks in compliance with safety policies, quality systems, and cGMP requirements. Take on additional duties as assigned with flexibility and adaptability. External Manufacturing & Supplier Quality. Medical Device Regulatory Compliance (FDA, ISO 13485, 21 CFR Part 820). Requirements
46 years in a regulated medical device or life sciences manufacturing environment. Strong background in Supplier Quality Engineering. Hands-on production line experience including validation activities. Expertise in NC/CAPA, FMEA, Design Control, and New Product Introduction (NPI). Prior experience with Pharmaceutical or similar organizations is preferred. Critical thinking, detail-oriented, strong verbal and written communication skills. Demonstrated ability to lead projects within a regulated environment. Supervisory or team leadership experience; ability to drive timelines and project deliverables. Proficiency in Excel (chart creation, scheduling, tracking). Program or project management skillset. Seniority level
Mid-Senior level Employment type
Contract Job function
Quality Assurance Industries
Pharmaceutical Manufacturing
#J-18808-Ljbffr