Director, Quality Management Systems & Compliance

About the role

The Director of QMS & Compliance will provide strategic leadership to Enterprise Quality Management System (QMS) initiatives, drive audit/inspection readiness, and ensure high standards of quality and compliance in line with industry's best practices. Your Role:

• Collaborates with senior leadership to influence and align quality strategy with business objectives, ensuring that quality management processes support operational efficiency, risk management, and strategic growth.
• Acts as a key advisor on quality-related risks and opportunities, providing expert guidance to executive leadership on regulatory changes, compliance risks, and quality trends to inform strategic decision-making.
• Develops, harmonizes, consolidates and deploys standardized QMS frameworks, ensuring alignment with regulatory requirements and business needs.
• Proactively identifies, prioritizes, and leads projects aimed at improving quality compliance across all operational areas (Sites, CLS, etc.).
• Establishes harmonized processes and risk assessments to pinpoint compliance gaps and standardize remediation projects.
• Affords oversight to the internal and external audit planning and execution for all locations and functions, ensuring audit readiness and follow-up on findings.
• Manages relationships with Notified Bodies (NB) and supports sites in regulatory discussions and changes.
• Ensures consistency, robustness, and standardization of MR content and reporting structures across sites.
• Drives continuous improvement initiatives to enhance the structure and efficiency of Integrated Supply Chain (ISC) QMSs.
• Responsible for functional leadership of the QMS & Compliance Team, including succession planning and comprehensive talent management, driving employee selection, performance management, compensation management, and career development as well as planning, staffing, budgeting, managing priorities, and proposing/implementing methodological changes for a function/region/business.
• Facilitates cross-functional collaboration at a strategic level, working closely with other departments to address and resolve high-impact quality issues and ensure alignment with organizational quality objectives.
• Develops and maintains quality metrics and reports to track QMS performance, providing regular updates to management on quality performance and improvement initiatives.

Requirements

If you are the right fit, you have a minimum of 10+ years' experience in FDA regulated medical device environments, with extensive focus in QMS Compliance, as document control, internal audits, CAPA, and training programs, ensuring their effective implementation, compliance, and continuous improvement.

• You have a minimum of 5+ years' experience in functional/strategic leadership of quality teams/organizations within global, matrixed organizations.
• You have robust understanding and deep knowledge of FDA 21 CFR Part 820, ISO 13485, EUMDR and other global medical device standards.
• You have detailed knowledge in Risk Management (ISO 14971), PFMEA, root cause analysis and design transfer activities.
• You have extensive experience leading/supporting regulatory inspections (FDA, Notified Bodies) including Front Room expertise.
• You have extensive experience developing/maintaining quality metrics and reports to track QMS performance, providing regular updates to management on quality performance and improvement initiatives.

Qualifications

• A minimum of a Bachelor’s degree (Required) in Engineering, Life Sciences, or related technical field - Master’s degree preferred (MBA, MS, or equivalent).

Skills

• Strategic thinking and problem-solving skills.
• Excellent communication and interpersonal skills.
• Strong project management and leadership abilities.
• Ability to manage multiple priorities and deadlines.
• Knowledge of regulatory compliance and quality systems.
• Experience with quality assurance and quality control processes.

Benefits

Details about our benefits can be found here.

Pay

The pay range for this position in Plymouth, MN is $170,000 to $270,000.

Schedule

This is an Office role. May travel up to 25% (Domestic & International).