Senior Quality Design Assurance Engineer

Heraeus Medevio; Fridley (MN); On-site; USD 110,000 - 130,000; Full time

Benefits offered by this job

Medical, dental, vision coverage

401(k) with company match

Education reimbursement

Parental leave

Paid time off

Job summary

Heraeus Medevio is seeking a Quality Design Assurance Senior Engineer to lead QA activities on complex medical device projects. You will drive design controls, risk management, and verification/validation, ensuring robust, manufacturable products and compliance with QMS requirements.

This onsite role in Fridley, MN may require travel to White Bear Lake. You will mentor QA technicians and partner with engineering, regulatory, and operations to uphold high quality standards across development

Qualifications

• Bachelor degree in engineering or related field required.
• Experience in medical device industry as a Quality Assurance Engineer strongly preferred.
• Experience with ISO 13485, FDA QSR, Design Controls, GMP/GLP, ISO 14971.

Responsibilities

• Serve as the primary QA Engineer on complex product and process development projects.
• Lead QA development activities by creating Quality Plans, Traceability, and Risk Management Plans.
• Design and specify inspection strategies, test plans, and systems to meet specs and regulatory requirements.
• Initiate, review, and approve Nonconforming Product dispositions; perform root-cause analysis; implement corrective actions.
• Lead continuous improvement initiatives using CAPA and quality systems enhancements.
• Collaborate with engineering, manufacturing, regulatory, quality, and operations teams to maintain QMS compliance.
• Facilitate customer audits and assist with FDA/ISO inspections.
• Provide mentorship to QA Technicians and junior engineers; participate in training and quality improvement initiatives.
• Other duties as required.

Skills

Quality Assurance

Cross-functional collaboration

Documentation accuracy

Root-cause analysis

Problem-solving

Mentorship

Education

Bachelor degree in engineering

Master’s degree preferred

Tools

Minitab

Inspection tools

Test equipment

Job description

Heraeus Medevio is seeking a Quality Design Assurance Senior Engineer to lead QA activities on complex medical device projects. You will drive design controls, risk management, and verification/validation, ensuring robust, manufacturable products and compliance with QMS requirements.

This onsite role in Fridley, MN may require travel to White Bear Lake. You will mentor QA technicians and partner with engineering, regulatory, and operations to uphold high quality standards across development