Senior Quality Manager

Real Staffing; 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

Plymouth, Minnesota
Compensation: $145,000 - $200,000 Base Salary + Bonus Eligibility

About the Opportunity

An innovative medical device organization is seeking a Senior Quality Manager to serve as the Quality Management Representative (QMR) across a multi-site R&D and manufacturing campus. This high-visibility leadership role will oversee Quality Management System (QMS) compliance, regulatory strategy, audit readiness, and continuous improvement initiatives while partnering with cross-functional teams to ensure product quality and regulatory excellence.

Key Responsibilities

Quality Leadership & Compliance

• 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.Regulatory & Audit Management

• 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.

Quality Systems & Continuous Improvement

• Lead Non-Conformance (NCR) and Corrective and Preventive Action (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. cellence & Operational Support

• Manage participation in advanced quality improvement initiatives including Medical Device Discovery Appraisal Program (MDDAP) assessments utilizing Capability Maturity Model Integration (CMMI) methodologies.
• Conduct internal assessments and audits to evaluate compliance, identify risks, and strengthen quality processes.
• Support global sites through quality appraisals and best-practice sharing.
• Lead quality budgets and develop high-performing quality teams across multiple locations.

Qualifications

Required

• 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.

Preferred

• Deep knowledge of ISO 13485, FDA 21 CFR regulations, ISO 14971, and EU MDR requirements.
• Experience leading audits, inspections, CAPA, NCR, and enterprise quality initiatives.
• Strong leadership experience across cross-functional and global teams.
• Demonstrated success driving quality system improvements and organizational change. s Opportunity?

• Strategic leadership position with significant influence on quality and compliance activities.
• Opportunity to oversee quality operations across multiple facilities.
• High level of interaction with executive leadership, regulatory agencies, and global stakeholders.
• Strong compensation package, bonus eligibility, comprehensive benefits, and a flexible hybrid work environment.

This opportunity is ideal for experienced medical device quality leaders with expertise in quality systems, regulatory compliance, audits, CAPA management, and driving quality excellence across complex organizations.

EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

In addition to base pay, direct-hire employees may be eligible for client offered benefits such as medical, dental, and vision coverage, and paid leave where required by applicable law. Eligibility may vary based on factors such as location and hire date and is subject to change.