Design Assurance QA Engineer for NPD & Medical Devices

Biomerics LLC; Salt Lake City (UT); On-site; USD 95,000 - 120,000; Full time

Job summary

Biomerics LLC in Salt Lake City, UT, seeks a Design Assurance Quality Engineer to drive quality engineering across NPD and sustaining activities for medical devices.

You will partner with Design Engineering, Manufacturing, Operations, and Supplier Quality to ensure design controls, risk management, verification, validation, and regulatory requirements are incorporated from concept through transfer and commercialization.

Qualifications

• Experience supporting NPD, design transfer, and sustaining activities for medical devices.
• Strong knowledge of design controls, risk management, verification and validation.
• Proficiency with regulatory requirements (FDA, ISO 13485) and CAPA processes.

Responsibilities

• Provide Quality Engineering support across the product lifecycle from concept to production.
• Maintain DHF and Engineering Project File documentation.
• Collaborate with cross-functional teams to ensure regulatory and quality requirements are met.

Skills

Quality engineering

Design assurance

Risk management

Design controls

Verification and validation

Regulatory compliance

Cross-functional collaboration

Education

Bachelor's degree in engineering

Tools

QMS software

Documentation systems

Job description

Biomerics LLC in Salt Lake City, UT, seeks a Design Assurance Quality Engineer to drive quality engineering across NPD and sustaining activities for medical devices.

You will partner with Design Engineering, Manufacturing, Operations, and Supplier Quality to ensure design controls, risk management, verification, validation, and regulatory requirements are incorporated from concept through transfer and commercialization.