Senior Quality Engineer - Medical Devices (CAPA)

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

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.