Senior Supplier Quality Engineer, Regulated Medical Devices

Katalyst CRO; Indianapolis (IN); Vor Ort; USD 90.000 - 120.000; Vollzeit

Zusammenfassung

Katalyst CRO is seeking a Supplier Quality Specialist to support supplier quality initiatives, manufacturing transfers, and new product implementations in a regulated environment. You will collaborate with engineering, manufacturing, procurement, and suppliers to ensure product quality and process compliance.

You will review PFMEA, control plans, MSA, SPC, and validation protocols; coordinate audits; drive CAPA/SCAR investigations; support NPI and engineering changes while maintaining regulatory

Qualifikationen

• Bachelor's degree in Engineering or related technical discipline.
• 5+ years in Supplier Quality, Manufacturing Quality, or Quality Engineering within a regulated industry.
• Strong knowledge of APQP, PPAP (or SPPA), PFMEA, Control Plans, MSA, SPC, and process validation.
• Experience with supplier quality systems, CAPA, SCAR, Client, nonconformance investigations, and corrective/preventive actions.
• Familiarity with manufacturing transfers, product launches, engineering change management, or NPI activities.
• Knowledge of ISO 13485, FDA Quality System Regulations, or comparable quality standards.
• Excellent analytical, communication, and cross-functional collaboration skills.

Aufgaben

• Collaborate with Engineering, Manufacturing, Procurement, and supplier partners to establish quality requirements and identify potential risks.
• Support supplier qualification, onboarding, and quality planning activities for new and existing products.
• Review and contribute to quality documentation including PFMEA, Control Plans, Process Flow Diagrams, MSA, SPC, and validation protocols.
• Coordinate supplier audits, performance evaluations, and continuous improvement initiatives.
• Investigate supplier-related quality concerns using CAPA, SCAR, Client, 8D, and root cause analysis methodologies.
• Support manufacturing transfer, design transfer, and engineering change activities while ensuring compliance with quality standards.
• Assist with process validation efforts, including IQ/OQ/PQ, equipment qualifications, validation builds, and production readiness.
• Partner with cross-functional teams to support regulatory compliance, quality objectives, and production launch activities.
• Contribute to New Product Introduction (NPI), supplier development, and sustaining engineering projects.

Kenntnisse

Analytical thinking

Cross-functional collaboration

Regulated industry experience

Strong communication

Problem solving

Ausbildung

Bachelor's degree in Engineering or related technical discipline

Tools

CAPA system

SCAR process

Nonconformance investigations

PFMEA

Control Plans

MSA

SPC

8D problem solving

Jobbeschreibung

Katalyst CRO is seeking a Supplier Quality Specialist to support supplier quality initiatives, manufacturing transfers, and new product implementations in a regulated environment. You will collaborate with engineering, manufacturing, procurement, and suppliers to ensure product quality and process compliance.

You will review PFMEA, control plans, MSA, SPC, and validation protocols; coordinate audits; drive CAPA/SCAR investigations; support NPI and engineering changes while maintaining regulatory