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Real

Senior Quality Engineer

Real, Minneapolis, Minnesota, United States, 55400

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Senior Quality Engineer

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Real

We're hiring a Senior Quality Engineer for a leading medical device company in Minneapolis, MN.

Base Pay Range $115,000.00/yr - $150,000.00/yr

Role Highlights

Ensure compliance with FDA, ISO 13485, EU MDR

Lead CAPA investigations, non-conformance resolution, and process validation (IQ/OQ/PQ)

Collaborate with R&D and manufacturing to integrate quality into product design

Support audits, supplier quality, and regulatory submissions (FDA 510(k), CE Mark)

Drive continuous improvement using tools like FMEA and SPC

Requirements

Bachelor's in Engineering or related field

6+ years in medical device quality engineering

Strong knowledge of FDA QSR, ISO 13485, EU MDR

Experience with process validation and quality tools

Salary: $115K-$150K + comprehensive benefits

Interested? Reply with your resume or reach out for details!

EOE Statement:

Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

In addition to base pay, direct-hire employees may be eligible for client offered benefits such as medical, dental, and vision coverage, and paid leave where required by applicable law. Eligibility may vary based on factors such as location and hire date and is subject to change.

Seniority level

Mid-Senior level

Employment type

Full-time

Job function

Quality Assurance

Medical Equipment Manufacturing

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To find out more about Real, please visit www.realstaffing.com

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