Director, Quality Management Systems & Compliance

Director, Quality Management Systems & Compliance Skip to main content# Careers Director, Quality Management Systems & Compliance page is loaded## Director, Quality Management Systems & Compliance Apply locations:
Plymouth, Minnesota, United Statestime type:
Full time posted on:
Posted Todayjob requisition :
584974### Job Title Director, Quality Management Systems & Compliance###

Job Description 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.
* Develop, harmonize, consolidate and deploy standardized QMS frameworks, ensuring alignment with regulatory requirements and business needs.
* Proactively identify, prioritize, and lead projects aimed at improving quality compliance across all operational areas (Sites, CLS, etc.).
* Establish harmonized processes and risk assessments to pinpoint compliance gaps and standardize remediation projects.
* Assist in overseeing the internal and external audit planning and execution for all locations and functions, ensuring audit readiness and follow-up on findings.
* Manage relationships with Notified Bodies (NB) and support sites in regulatory discussions and changes.
* Ensure consistency, robustness, and standardization of MR content and reporting structures across sites
* Drive 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.
** You're the right fit if:
*** 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.
* You have a minimum of a Bachelor’s degree (Required) in Engineering, Life Sciences, or related technical field - Master’s degree preferred (MBA, MS, or equivalent)
* You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.
** How we work together:
** We believe that…