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Quality Design Assurance Engineer I / II
Minor Hotels Europe and AmericasQuality Design Assurance Engineer supporting design and development of medical devices at Heraeus. Collaborating with project teams to ensure compliance with quality standards and regulations.
Posted 5/14/2026full-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
- Collaborate across functional areas to support and drive project deliverables to completion
- Support design and specifications for inspection and testing plans/procedures/systems
- Review, and approve disposition for nonconforming product
- Support efforts to continuously improve quality management systems and product quality,
- Represent Quality Assurance on product development teams
- Provide input for quality management review
- Support customer audits and external audits such as FDA and ISO
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
- Experience with the use and application of gages, inspection tools, and test equipment strongly preferred
- 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 read and understand component/product specifications
- Customer-focused mindset and ability to work collaboratively across functional groups
- Highly organized and capable of managing multiple projects concurrently
- Good written and verbal communication skills, team building skills, basic PC skills, and working knowledge of Microsoft Word, Excel, and Minitab
Benefits
Comp & perks- Comprehensive medical coverage
- Dental and vision insurance
- 401(k) plan with company match
- Education reimbursement
- Paid parental leave
- Paid time off
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
engineering fundamentalsquality assuranceinspection toolstest equipmentISO 13485FDA Quality System RegulationsDesign ControlsGood Manufacturing PracticesGood Laboratory PracticesISO 14971
Soft Skills
customer-focused mindsetcollaborative workhighly organizedproject managementwritten communicationverbal communicationteam building