Senior Quality Assurance Engineer — Medical Devices
Compensation
$100k – $125k /yr
Employment type
Full-time
Work setting
On-site
Location
Osseo, MN
Schedule
Day shift
Posted
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Job overview
The Senior Quality Assurance Engineer — Medical Devices role is onsite in Osseo, MN, with stated annual pay of $100,000–$125,000. Nextern partners with original equipment manufacturers, clinicians, and innovators to design, develop, and manufacture medical devices across the product lifecycle. The engineer provides operational quality oversight for manufacturing programs and supports development activities through manufacturing readiness, audits, and clinical builds. The role helps maintain compliant quality systems and product documentation while supporting reliable transitions into commercial manufacturing.
What you'll do
- Author and approve procedures, work instructions, and forms
- support internal audits and inspection readiness
- trend quality metrics and drive corrective and preventive actions
- oversee incoming inspection and supplier corrective actions
- provide quality oversight for qualification activities
- manage nonconformances and CAPAs
- review batch records
- support line clearances and first-article inspections
- maintain Design History Files
- review changes and product complaints
- support audits and product lifecycle management.
What we're looking for
- Skills & competencies
- senior quality assurance engineermedical devicesquality engineeringdesign assurancecapaiso 1348521 cfr 820osseo mnnextern$100,000–$125,000 per yearmanufacturing qualitydesign history files
- Work arrangement
- Weekend coverage required
Benefits & perks
- Medical, dental, and vision care
- retirement plan with company match
- paid time off, personal days, and birthday holiday
- wellness resources
- life insurance
- Minnesota paid leave
- short- and long-term disability.
Why this role
The role supports medical-device programs across development and commercial manufacturing and includes responsibility for quality-system and regulatory compliance.
About the employer
Nextern is hiring for this role. Industry: Engineering Services. Sector: 54.
Additional details
- Industry sector
- 54
- Industry
- Engineering Services
- Occupation code
- 17-2112.00
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Listing ID: 304a04ec-5eea-4594-9412-ce9da77de7cd