Senior Quality Engineer

Real; Minneapolis (MN); On-site; USD 115,000 - 150,000; Full time

Benefits offered by this job

Comprehensive benefits

Medical, dental, and vision coverage

Job summary

A leading medical device company in Minneapolis is seeking a Senior Quality Engineer to ensure compliance with FDA and ISO standards. The role involves leading CAPA investigations, collaborating with R&D, and supporting quality audits and submissions. Candidates should have a Bachelor's in Engineering, over 6 years of relevant experience, and strong knowledge of quality tools. This is a full-time position offering a competitive salary of $115,000 to $150,000 and comprehensive benefits.

Qualifications

• 6+ years in medical device quality engineering.
• Strong knowledge of FDA QSR, ISO 13485, EU MDR.
• Experience with process validation and quality tools.

Responsibilities

• Ensure compliance with FDA, ISO 13485, EU MDR.
• Lead CAPA investigations and process validation.
• Collaborate with R&D and manufacturing for quality integration.
• Support audits and regulatory submissions.

Skills

Knowledge of FDA QSR

ISO 13485

Process validation

FMEA

SPC

Education

Bachelor's in Engineering or related field

Job description

Join to apply for the Senior Quality Engineer role at 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