Senior Quality Engineer, Medical Devices – Onsite

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

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.