Senior Quality Engineer - Medical Devices, CAPA/Validation

BioTalent; Minneapolis (MN); On-site; USD 80,000 - 100,000; Full time

Benefits offered by this job

Competitive salary

Performance-based bonus

Comprehensive benefits package

Health savings account

Paid time off

Retirement savings plan with employer match

Job summary

A leading medical device company is seeking a Senior Quality Engineer to provide technical quality support. This role involves collaboration across engineering, operations, and quality teams to ensure manufacturing readiness and compliance. Candidates should have 5–8 years of experience in a regulated medical device environment, a Bachelor's degree in a relevant field, and strong communication skills. The position offers a competitive salary and a comprehensive benefits package, including performance-based bonuses and opportunities for professional development.

Qualifications

• 5–8 years of experience in a regulated medical device manufacturing environment.
• Experience with root-cause analysis and auditing.
• Ability to sit or stand for extended periods.

Responsibilities

• Support and lead qualification activities required for manufacturing process release.
• Lead customer complaint handling and related CAPA activities.
• Promote adherence to Quality Management System (QMS) and Good Manufacturing Practices (GMP).

Skills

Root-cause analysis

Process qualification

Validation

Strong communication skills

Collaborative mindset

Education

Bachelor’s degree in Engineering, Science, or Manufacturing

Tools

Quality software tools

Job description

A leading medical device company is seeking a Senior Quality Engineer to provide technical quality support. This role involves collaboration across engineering, operations, and quality teams to ensure manufacturing readiness and compliance. Candidates should have 5–8 years of experience in a regulated medical device environment, a Bachelor's degree in a relevant field, and strong communication skills. The position offers a competitive salary and a comprehensive benefits package, including performance-based bonuses and opportunities for professional development.