Quality Compliance Manager, Management Controls

Changing lives. Building Careers.

Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what’s possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.

The Quality Compliance Manager for Management Controls will support the activities associated with Management Review. The role will lead the planning, metrics compilation and documentation of the Management Review meetings. Subject matter expert with extensive knowledge of quality compliance.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

• Management Review Process:
• Lead and coordinate the planning, execution, and follow-up of management review meetings, ensuring they are completed on time and in full compliance with relevant regulations (e.g., ISO 13485, FDA QSR).
• Prepare and present accurate metrics, quality trends, and other relevant data during management review meetings to senior leadership.
• Document meeting minutes, action items, and decisions made during the reviews.
• Compliance Monitoring & Reporting:
• Ensure that the quality management system (QMS) and associated controls meet regulatory and industry standards, ensuring full compliance with medical device regulations such as FDA, ISO, and other relevant standards.
• Ensure the data integrity of all the data analyzed for management review meetings.
• Develop and compile monthly/quarterly reports summarizing key metrics, trends, and performance indicators to monitor and improve the quality management process.
• Action Item Tracking and Follow-up:
• Track and manage action items arising from management reviews, ensuring they are assigned to appropriate departments and completed within the specified timeframe.
• Ensure documentation related to the action items is updated, reviewed, and approved in a timely manner.
• Cross-Functional Coordination:
• Collaborate with cross-functional teams (e.g., R&D, Manufacturing, Regulatory, Supply Chain) to facilitate the implementation of management review action items.
• Serve as a liaison between teams to ensure that compliance initiatives are communicated and addressed at all relevant sites.
• Coordinate with various sites to ensure that quality metrics are collected, analyzed, and reported consistently across the organization.
• Continuous Improvement:
• Actively identify opportunities for improvement in the management review process, QMS effectiveness, and regulatory compliance efforts.
• Drive initiatives to streamline and enhance reporting, action tracking, and documentation processes.
• Stay up to date with industry regulations and standards and implement changes to the compliance framework as necessary.
• Documentation & Auditing:
• Maintain and control all documentation related to the management review process in line with the company’s document control procedures.
• Support internal and external audits by providing relevant reports and records as requested.
  

Required Qualifications

• Bachelor’s degree in Engineering, or Sciences or relevant Technical Field required.
• Bachelor degree with 10 years of experience or equivalent education and years of experience required. Minimum 8 years experience in quality/medical device industry.
• Strong knowledge of management review meetings and execution of management review meetings in regulated environments
• Proficiency preparing management review slides and documenting meeting minutes
• Strong analytical and problem-solving abilities to identify trends, issues, and opportunities.
• This position may require travel up to 25% of the time
  
  

Preferred Qualifications

• Minimum of 10 years experience in quality/medical device industry
• Certificate in quality management (e.g., ASQ Certified Quality Auditor, Six Sigma)
• Experience with FDA inspections and audits
  
  

Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.

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