Design Quality Engineer - Medical Devices & Design Control

Katalyst CRO; Denver (CO); On-site; USD 80,000 - 110,000; Full time

Job summary

Katalyst CRO is seeking a Design Quality Engineer (DQE) in Denver, Colorado. The DQE will ensure product compliance with regulatory standards and quality requirements. This role collaborates closely with R&D and manufacturing to embed quality in product design.

Candidates should possess a Bachelor's degree in a relevant field and have over 5 years' experience in FDA regulated environments, emphasizing design assurance and risk management.

Qualifications

• Bachelor's degree in Medical Sciences, Industrial Engineering, or related field.
• 5+ years of experience in FDA regulated medical device environments.
• Detailed knowledge of 21 CFR Parts 820 and ISO 13485.

Responsibilities

• Ensure compliance with Design Control requirements.
• Participate in design planning and design reviews.
• Manage and execute CAPA processes.

Skills

Knowledge of medical device regulations

Change Management experience

Design Assurance/Control

Risk Management

Detailed experience in design quality tools

Education

Bachelor's Degree in Medical Sciences or equivalent

Job description

Katalyst CRO is seeking a Design Quality Engineer (DQE) in Denver, Colorado. The DQE will ensure product compliance with regulatory standards and quality requirements. This role collaborates closely with R&D and manufacturing to embed quality in product design.

Candidates should possess a Bachelor's degree in a relevant field and have over 5 years' experience in FDA regulated environments, emphasizing design assurance and risk management.