Medical Device Design Quality Engineer - Impactful QA & V&V

Katalyst CRO; Bothell (WA); On-site; USD 110,000 - 150,000; Full time

Job summary

Katalyst CRO is seeking a Product Design Quality Engineer to support quality throughout the product development lifecycle in compliance with regulatory requirements and design control processes.

The role partners with R&D, Regulatory Affairs, Manufacturing, and Supplier Quality to ensure manufacturing readiness and effective risk control measures, including FMEA and CAPA investigations.

Qualifications

• Bachelor's degree in a technical discipline as listed in the posting.
• 5+ years in Design Quality/Design Assurance/Quality Engineering in FDA-regulated medical devices.
• Strong knowledge of Design Controls and product lifecycle management.
• Experience with V&V, design traceability, change management, and manufacturing transfer.

Responsibilities

• Support Design Control activities across product development per FDA and regulatory requirements.
• Participate in design planning reviews and V&V activities to meet quality objectives.
• Review and approve design documentation, inputs, outputs, specs, and records.
• Maintain Design History Files, DMRs, and related quality docs.
• Review ECRs/ECOs and changes to ensure proper change control.

Skills

Quality Engineering

Design Controls

Regulatory Knowledge

Cross-functional Collaboration

V&V

Education

Bachelor's degree in Engineering or related

Tools

QMS Software

CAPA System

Document Management System

Job description

Katalyst CRO is seeking a Product Design Quality Engineer to support quality throughout the product development lifecycle in compliance with regulatory requirements and design control processes.

The role partners with R&D, Regulatory Affairs, Manufacturing, and Supplier Quality to ensure manufacturing readiness and effective risk control measures, including FMEA and CAPA investigations.