Quality Design Assurance Engineer I – II

Minor Hotels Europe and Americas

Quality Design Assurance Engineer at Heraeus focusing on complex medical device design and development projects in Fridley, Minnesota. Coordinates quality assurance activities and ensures regulatory compliance.

Posted 6/2/2026full-timeFridley • Minnesota • 🇺🇸 United StatesMid-LevelSenior💰 $70,000 - $90,000 per yearWebsite

About the role

Key responsibilities & impact

Participate in complex medical device design and development projects
Support design and specifications for inspection and testing plans/procedures/systems
Review, and approve disposition for nonconforming product
Represent Quality Assurance on product development teams
Support customer audits and assist as needed with external audits

Requirements

What you’ll need

Bachelor’s degree in Engineering or related field strongly preferred
Basic knowledge of engineering fundamentals
Understanding of the medical device industry and quality assurance strongly preferred
Practical experience/familiarity with ISO 13485, FDA Quality System Regulations, Design Controls, Good Manufacturing Practices, Good Laboratory Practices, ISO 14971, MDR, sterilization processes, cleanrooms, and other applicable standards
Ability to develop practical technical knowledge related to products that the position will support

Benefits

Comp & perks

Comprehensive medical, dental, and vision coverage
401(k) plan with company match
Education reimbursement
Paid parental leave
Paid time off

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

engineering fundamentalsISO 13485FDA Quality System RegulationsDesign ControlsGood Manufacturing PracticesGood Laboratory PracticesISO 14971MDRsterilization processescleanrooms

Soft Skills

quality assurance representationcustomer audit supportexternal audit assistance

Certifications

Bachelor’s degree in Engineering