Senior Quality Leader - Medical Devices, QMS & Compliance

Real Staffing Group; Massachusetts; Hybrid; USD 145,000 - 200,000; Full time

Job summary

Real Staffing Group is seeking a Senior Quality Manager to serve as the Quality Management Representative (QMR) across multiple facilities within the Twin Cities campus, including R&D and manufacturing. You will lead QMS implementation, regulatory strategy, and audit readiness to ensure product quality and compliance.

The role requires 8+ years in quality/engineering, 3+ years in leadership, and deep knowledge of FDA/ISO regulations.

Qualifications

• Bachelor's degree in Engineering, Science, or related technical discipline.
• 8+ years of experience in Quality, Manufacturing, Engineering, or 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

• Lead Quality Management System (QMS) implementation and maintenance across multiple facilities.
• Provide regulatory strategy and guidance for FDA/ISO compliance and audits.
• Act as primary liaison during regulatory inspections and external audits.
• Oversee NCR/CAPA programs and quality system effectiveness through reviews and assessments.
• Drive continuous improvement initiatives to enhance quality, reliability, and cost efficiency.

Skills

Quality leadership

Regulatory compliance

QMS implementation

CAPA management

Audit readiness

Education

Bachelor's degree in Engineering or Science

Job description

Real Staffing Group is seeking a Senior Quality Manager to serve as the Quality Management Representative (QMR) across multiple facilities within the Twin Cities campus, including R&D and manufacturing. You will lead QMS implementation, regulatory strategy, and audit readiness to ensure product quality and compliance.

The role requires 8+ years in quality/engineering, 3+ years in leadership, and deep knowledge of FDA/ISO regulations.