Senior Quality Engineer

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

The Senior Quality Engineer is responsible for providing technical quality support to ensure customer, regulatory, and internal requirements are clearly understood and effectively implemented. This role works cross-functionally with engineering, operations, supply chain, and quality teams to support qualification, validation, and manufacturing readiness activities.

The position plays a key role in nonconformance management, supplier quality, complaint handling, and corrective and preventive action (CAPA) processes. In addition, the Senior Quality Engineer provides leadership and oversight to inspection and quality control functions to ensure consistent, high-level performance and product quality.

Work Location / Schedule

This role is primarily onsite at a manufacturing facility and may require occasional travel to other operational locations. Relocation assistance is not provided.

Key Responsibilities

• Support and/or lead qualification activities required for manufacturing process release
• Support and/or contribute to process validation activities associated with manufacturing transfers
• Partner with manufacturing and engineering teams to drive effective nonconformance investigation and resolution
• Lead or support customer complaint handling and related CAPA activities
• Support purchasing and receiving inspection activities to ensure raw material accuracy and timeliness
• Support development and transition of manufacturing processes and controlled documentation from prototype through commercial production
• Promote adherence to Quality Management System (QMS), Good Manufacturing Practices (GMP), and Good Documentation Practices (GDP)
• Contribute to and support the internal audit program
• Participate in supplier, customer, and external audits as needed
• Lead and direct quality inspection teams to ensure high product quality and throughput
• Support production floor quality objectives, including in-line inspection, lean initiatives, and scrap reduction
• Perform other duties as assigned

Required Qualifications

• 5–8 years of experience in a regulated medical device manufacturing environment (ISO/FDA)
• Bachelor’s degree in Engineering, Science, Manufacturing, or equivalent relevant experience
• Experience with root-cause analysis, process and equipment qualification, validation, metrology, automation, and auditing
• Strong communication skills, collaborative mindset, and confidence working cross-functionally
• Proficiency with common business and quality software tools
• Ability to sit or stand for extended periods

Preferred Qualifications

• Experience with Class II or Class III medical devices
• Background in contract manufacturing and extrusion processes

Compensation and Benefits

• Competitive salary based on experience, education, and market factors
• Eligibility for an annual performance-based bonus
• Comprehensive benefits package, including medical, dental, vision, disability coverage, and supplemental insurance options
• Health savings account with employer contribution
• Paid time off, paid holidays, and sick leave
• Parental leave
• Retirement savings plan with employer match
• Opportunities for professional development and career advancement