Senior Quality Lead & QMR — Multi-Site Medical Devices

Real; Plymouth (MN); Hybrid; USD 145,000 - 200,000; Full time

Job summary

Real is seeking a Senior Quality Manager to serve as the Quality Management Representative (QMR) across a Twin Cities campus medical device operation. You will lead QMS implementation, regulatory strategy, audits, and continuous improvement to ensure product quality and regulatory excellence.

This high-visibility leadership role partners with cross-functional teams, oversees FDA/ISO compliance, CAPA/NCR programs, and drives quality metrics, training, and risk management across multiple locations.

Qualifications

• Bachelor's degree in Engineering, Science, or a related technical discipline.
• 8+ years of experience in Quality, Manufacturing, Engineering, or a related field.
• 3+ years of leadership or supervisory experience.
• Strong understanding of medical device regulations and quality systems.
• Experience operating within FDA and ISO regulated environments.

Responsibilities

• Serve as the Quality Management Representative (QMR) for multiple facilities within a Twin Cities campus environment.
• Lead implementation and maintenance of site Quality Management Systems (QMS).
• Ensure ongoing compliance with FDA, ISO, and global regulatory requirements.
• Provide strategic quality direction that supports business objectives and product compliance.
• Act as the primary quality liaison during regulatory inspections and external audits.
• Support legal manufacturing quality responsibilities across internal and external manufacturing locations.
• Provide technical guidance for regulatory decisions and compliance strategies.
• Oversee quality system effectiveness through management reviews and compliance assessments.
• Lead Non-Conformance (NCR) and CAPA programs as the site subject matter expert.
• Drive continuous improvement initiatives focused on quality, reliability, compliance, and cost reduction.
• Oversee employee qualification, training, and quality system ownership programs.
• Monitor and improve organizational quality metrics and risk management activities.

Skills

Quality leadership

Regulatory compliance

Audits

CAPA management

NCR management

Education

Bachelor's degree in Engineering, Science, or related technical discipline

Job description

Real is seeking a Senior Quality Manager to serve as the Quality Management Representative (QMR) across a Twin Cities campus medical device operation. You will lead QMS implementation, regulatory strategy, audits, and continuous improvement to ensure product quality and regulatory excellence.

This high-visibility leadership role partners with cross-functional teams, oversees FDA/ISO compliance, CAPA/NCR programs, and drives quality metrics, training, and risk management across multiple locations.