Cook Group

Director – Post Market Quality Assurance

Cook Group

full-time

Posted on:

Location Type: Office

Location: Bloomington • United States

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Job Level

Lead

About the role

  • Direct and maintain a scalable, global structure for post market quality assurance ensuring clear communication and alignment with regional regulatory needs and business objectives.
  • Develop and lead strategic vision and objectives for the global post market quality assurance team, ensuring alignment with overall corporate goals, regulatory requirements, and operational excellence initiatives.
  • Collaborate closely with global functional leadership to ensure local market needs are integrated into global strategies.
  • Provide leadership and mentorship and technical expertise to a diverse geographically dispersed post market quality assurance team, ensuring alignment with global standards and regional needs.
  • Oversee and manage post market quality assurance budgets, including cost tracking, and strategic planning to support global operational priorities.
  • Oversee and ensure that all post market quality activities comply with applicable regulations, including but not limited to: ISO13485, US FDA CFR Part 820, State Council Order No. 739- China, PMD Act, Law Act 145- Japan, Medical Device Management Act- Taiwan, Medical Devices Act- Korea, Good Distribution Practices-Thailand, etc. Proactively monitor regulatory changes and lead updates to post market quality assurance to maintain compliance.
  • Drive adherence to relevant Quality Management Systems and Business Processes, promoting a culture of quality and organizational effectiveness.
  • Engage effectively with stakeholders across all levels of the global organization, including regional regulatory agencies, to foster strategic relationships, influence policy, and ensure compliance. Lead cross-functional collaboration to optimize post market quality assurance processes.
  • Foster a high-performance culture focused on talent development, succession planning, and continuous improvement.
  • Establish and maintain global best practices, standardised policies, and/or procedural controls as needed to ensure consistency, accuracy and compliance of PMQA work outputs and systems. Balance standardization with regional flexibility where necessary.
  • Champion a continuous improvement culture by leading initiatives that leverage AI and digital tools, automation, and innovate processes to enhance efficiency, accuracy and compliance in PMQA activities.
  • Ensure local and corporate entities fulfil PMQA economic operator roles and responsibilities, including those for in-country representatives.
  • Oversee the health of the PMQA QMS through proactive data collection, trend analysis, and implementation of improvement actions.
  • Direct leadership to ensure compliance of the PMQA QMS with global QA policies, procedures, and direction.
  • Oversee customer complaints, recall, and adverse reporting processes, ensuring appropriate handling, escalation, and resolution by relevant teams.
  • Serve as the Global Process Owner and represent Cook during internal and external audits.
  • Represent PMQA globally, participating in working groups and supporting the voice of Cook and patients in industry guidance and regulation commentary.
  • Ensure post market quality assurance team members possess the requisite technical skills, experience, and training to perform their work.
  • Provide strategic recommendations for workforce planning and contribute significantly to employee related decisions and development initiatives.
  • Foster and maintain a positive, inclusive and productive work environment aligned with Cook’s culture and values.
  • Maintain overall accountability for PMQA QMS performance, communicating effectiveness and improvement needs to executive management and ensuring timely corrective actions.

Requirements

  • Bachelor’s degree or equivalent in Quality, Science or Engineering is required.
  • A minimum of 12 years’ experience in a regulated industry in a similar role preferred.
  • Minimum of 8 years management experience leading Quality professionals.
  • Working knowledge and experience applying medical device regulations and standards.
  • Knowledge and experience of Quality Assurance, Quality Engineering and Regulatory Affairs, manufacturing and distribution operations.
  • Knowledge of customer complaint management and recall management globally.
  • Strong leadership and team management capabilities, with demonstrated success in guiding and developing global teams.
  • Ability to lead and deliver multiple complex global projects simultaneously within deadlines.
  • Ability to develop and maintain strong working relationships with internal and external stakeholders.
  • Adapt to dynamic landscapes and organizational changes, with the ability to adjust quickly and effectively in a change-driven environment.
  • Excellent problem-solving abilities and the capacity to work effectively both collaboratively and independently in environments with minimal supervision.
  • Excellent organizational and planning abilities, complemented by keen attention to detail.
  • Demonstrated ability to work in a fast-paced, high-pressure environment and meet deadlines.
  • Collaborative team player with a proven ability to foster trust, open communication, and effective collaboration across diverse teams and stakeholders.
  • Effective communication and interpersonal skills to build relationships across diverse geographies and cultures.
  • Self-motivated and proactive, with a passion for driving quality and operational excellence.
  • Flexibility to work across global time zones as required.
Benefits
  • Willingness and availability to travel globally on company business.
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
Quality AssuranceQuality EngineeringRegulatory AffairsISO13485US FDA CFR Part 820Medical Device Management ActGood Distribution PracticesData CollectionTrend AnalysisProject Management
Soft Skills
LeadershipTeam ManagementProblem-SolvingOrganizational SkillsCommunication SkillsCollaborationAdaptabilityMentorshipContinuous ImprovementStakeholder Engagement
Certifications
Bachelor’s Degree in QualityBachelor’s Degree in ScienceBachelor’s Degree in Engineering