Design Quality Engineer — Medical Devices & QMS

Katalyst CRO; Bothell (WA); On-site; USD 75,000 - 95,000; Full time

Job summary

Katalyst CRO is seeking a Design Quality Engineer to ensure compliance with regulatory standards in product design development. This role involves participating in cross-functional design reviews and managing quality audits.

The ideal candidate will have at least 5 years' experience in FDA regulated environments and a Bachelor's degree in a relevant field. Strong knowledge of medical device regulations is essential.

Qualifications

• 5+ years' experience in FDA regulated medical device environments.
• Experience in identifying and promoting quality processes.
• Detailed knowledge of ISO 13485 and FDA regulations.

Responsibilities

• Ensure compliance with Design Control requirements.
• Participate in design planning and reviews.
• Facilitate FMEA and hazard analysis.

Skills

Knowledge of medical device regulations

Design Assurance/Control

Risk Management

Change Management

Education

Bachelor's degree in medical sciences or related field

Job description

Katalyst CRO is seeking a Design Quality Engineer to ensure compliance with regulatory standards in product design development. This role involves participating in cross-functional design reviews and managing quality audits.

The ideal candidate will have at least 5 years' experience in FDA regulated environments and a Bachelor's degree in a relevant field. Strong knowledge of medical device regulations is essential.