Senior Quality Engineer - Med Device Quality Lead

Quality Tech Services; BLOOMINGTON (MN); On-site; USD 109,000 - 151,000; Full time

Benefits offered by this job

401k with company match

Onsite health clinics

Discretionary holiday bonus program

Cretex University

Employee assistance program

Job summary

Quality Tech Services in Bloomington, MN is seeking a Senior Quality Engineer to support manufacturing with quality assurance, improvements, and technical guidance across processes.

You will lead quality initiatives, perform audits, develop inspection methods, mentor junior engineers, and collaborate with sister companies to implement best practices while ensuring regulatory compliance and robust metrology and validation activities.

Qualifications

• Bachelor's degree in Mechanical, Industrial, or a related engineering field.
• 10 years of engineering experience in a regulated manufacturing environment.
• Knowledge of quality systems, regulatory requirements, and industry standards.
• Demonstrated leadership and strong written/spoken communication.
• Experience with ERP systems and Microsoft Office tools.

Responsibilities

• Serve as customer-facing quality representative for development projects, complaints and feedback.
• Develop and execute inspection methods, PFMEAs, and related reports.
• Act as quality interface for production teams addressing customer issues with RCAs and preventive actions.
• Conduct internal audits and support external audits; close findings with corrective actions.
• Coach and mentor Quality Engineer levels I-III.
• Serve as SME in one or more ASQ QE Body of Knowledge areas.
• Lead or participate in large, company-wide quality improvement projects.
• Collaborate with sister companies to implement best practices.
• Support validation activities for processes, equipment, and metrology.

Skills

Leadership

Communication skills

Attention to detail

Teamwork in fast-paced environment

Problem solving

Education

Bachelor's Degree in Mechanical, Industrial, or in another Engineering or Physical Science

Tools

ERP systems

Microsoft Office

Quality systems

Job description

Quality Tech Services in Bloomington, MN is seeking a Senior Quality Engineer to support manufacturing with quality assurance, improvements, and technical guidance across processes.

You will lead quality initiatives, perform audits, develop inspection methods, mentor junior engineers, and collaborate with sister companies to implement best practices while ensuring regulatory compliance and robust metrology and validation activities.