Senior Quality Engineer

Redbock - an NES Fircroft company; Minnesota; On-site; USD 90,000 - 120,000; Full time

Job summary

Redbock - an NES Fircroft company is seeking a Quality Engineering professional to own service development quality activities for new product launches and sustaining changes in a regulated medical device environment.

You will serve as the Quality Engineering point of contact for capital equipment, collaborating with Service, Engineering, and Quality, and ensuring compliance with quality systems and regulatory requirements.

Qualifications

• Bachelor's degree in Engineering or scientific discipline.
• Approximately 5 years of experience in medical device industry, preferably Quality Engineering or related function.
• Experience in medical device Quality organization as Quality Engineer, QA Specialist, or Design Assurance Engineer.
• Hands-on ownership of CAPA and nonconformance processes, including investigations and closure.
• Experience executing engineering change control and Quality System change management.

Responsibilities

• Own and execute Service Development Quality Engineering activities for new product launches and sustaining changes.
• Serve as the Quality Engineering point of contact for assigned capital equipment products, partnering with cross-functional teams to ensure compliance.
• Author, develop, revise, and approve service quality documentation (Service Plans, Work Instructions, Checklists, Risk Analyses).
• Develop risk assessments for service procedures, equipment servicing, and field service activities.
• Lead and execute CAPA, nonconformance, and other quality investigations with root cause analysis and corrective actions.

Skills

Quality Engineering

CAPA investigations

Change control

Regulatory compliance

Cross-functional collaboration

Documentation

Root cause analysis

Education

Bachelor's degree in Engineering

Job description

• Own and execute Service Development Quality Engineering activities for new product launches, capital equipment releases, and sustaining engineering changes within a regulated medical device environment.
• Serve as the Quality Engineering point of contact for assigned capital equipment products, partnering with Service, Engineering, Quality, and cross-functional product teams to ensure service-related activities meet quality system and regulatory requirements.
• Author, develop, revise, and approve service-related quality documentation, including Service Plans, Service Work Instructions, Service Checklists, and Service Risk Analyses.
• Develop and document risk assessments related to service procedures, equipment servicing, product performance, and field service activities, ensuring identified risks are appropriately evaluated and addressed.
• Lead and execute CAPA, NCEP/nonconformance, and other quality investigations, including root cause analysis, impact assessments, corrective action development, implementation, and effectiveness verification through closure.
• Drive engineering and Quality System change control activities, including impact assessments, documentation updates, cross-functional reviews, required approvals, and implementation of approved changes.
• Own assigned Quality deliverables for product releases and sustaining changes, proactively tracking actions, resolving gaps, and driving completion in accordance with established timelines and quality requirements.
• Partner with Service Support and Customer Care teams to investigate field issues, assess service-related quality concerns, and implement appropriate corrective and preventive actions.
• Develop, revise, and maintain Quality System procedures, SOPs, and Work Instructions, including drafting new documentation and executing redlines to existing controlled documents.
• Evaluate service records, quality data, and equipment-related documentation to identify discrepancies, assess compliance, investigate trends, and improve service process consistency and system accuracy.
• Participate in technical reviews, risk assessments, and cross-functional discussions involving capital equipment quality, serviceability, repair processes, and ongoing product support.
• Support audit readiness by ensuring service and quality documentation is complete, accurate, traceable, and aligned with applicable medical device regulations and internal Quality System requirements.

Required Qualifications

• Bachelor's degree in Engineering, a scientific discipline, or a related field.
• Approximately 5 years of experience in the medical device industry, preferably in Quality Engineering, Service Quality, Design Assurance, or a closely related function.
• Experience working within a medical device Quality organization as a Quality Engineer, Quality Assurance Specialist, Design Assurance Engineer, or similar role.
• Demonstrated hands-on ownership of CAPA and nonconformance processes, including investigations, root cause analysis, corrective action implementation, and documented closure.
• Direct experience executing engineering change control and/or Quality System change management activities, including impact assessments, documentation, reviews, and approvals.
• Experience developing and documenting risk assessments, risk analyses, or FMEA-related deliverables rather than solely reviewing work completed by others.
• Experience authoring and maintaining controlled quality documentation, procedures, work instructions, and technical records.
• Background supporting medical device capital equipment, instrumentation, or electromechanical systems, particularly products requiring field service, maintenance, repair, troubleshooting, or ongoing service documentation.
• Ability to independently execute assigned Quality Engineering activities with limited guidance, exercise sound judgment, and drive deliverables to completion.
• Strong cross-functional communication, technical documentation, investigation, and project coordination skills.
• Ability to work onsite in Arden Hills, Minnesota, at least three days per week.