Supplier Quality Specialist

Job overview

The Supplier Quality Specialist role is onsite in Zionsville, IN. Compensation is not specified. The role supports supplier quality initiatives, manufacturing transfers, and new product implementation in a regulated manufacturing environment. The specialist works with suppliers and internal engineering, manufacturing, and procurement teams to establish quality requirements, assess risks, and resolve supplier-related quality issues. The work supports compliant processes, validated transfers, supplier development, and successful product launches.

What you'll do

• Collaborate with engineering, manufacturing, procurement, and suppliers on quality requirements and risks
• support supplier qualification, onboarding, and quality planning
• review and contribute to PFMEA, control plans, process flow diagrams, MSA, SPC, and validation protocols
• coordinate supplier audits and performance evaluations
• investigate supplier quality concerns using CAPA, SCAR, 8D, and root-cause methods
• support manufacturing and design transfers, engineering changes, process validation, equipment qualification, validation builds, production readiness, regulatory compliance, and NPI.

What we're looking for

Skills & competencies

supplier quality specialist

zionsville in

katalyst healthcares & life sciences

supplier quality

regulated manufacturing

quality planning

supplier audits

capa

scar

process validation

new product introduction

Work arrangement

• Weekend coverage required

Why this role

Medical-device or other regulated-industry experience is preferred. Respiratory care, ventilator, CPAP, or sleep-therapy product knowledge is a plus.

About the employer

Katalyst Healthcares & Life Sciences is hiring for this role. Industry: Employment Placement Agencies. Sector: 56.