Cook Medical · 1 day ago
Director, Post Market Quality Assurance
Bloomington, IN
Full-time
Onsite
Director/Executive
12+ years expCook Medical is a global leader in the medical device industry, and they are seeking a Director of Post Market Quality Assurance. This role is responsible for ensuring the effectiveness and compliance of post market processes within the global quality management system, providing leadership to global Quality Assurance teams and fostering a culture of collaboration and accountability.
Medical DeviceHardwareManufacturing
Responsibilities
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
Willingness and availability to travel globally on company business
Qualification
Required
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
Preferred
A minimum of 12 years' experience in a regulated industry in a similar role preferred
Working knowledge and experience applying medical device regulations and standards. ISO13485 and regional regulations for PMDA & TMG, MFDS, TFDA, US FDA, EUMDR, NMPA & SHMPA, and other health authorities desirable
Company
Cook Medical
Cook Medical is a medical device company that specializes in designing, manufacturing, and delivering invasive medical devices. It is a sub-organization of Cook Group.
10001+ employees
H1B Sponsorship
Cook Medical has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2023 (3)
2022 (2)
Funding
Current Stage
Late StageLeadership Team
G
Gayle Cook
Co-founder
Kelly Fischer
Senior Vice President and Chief Financial Officer
Recent News
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