Director, Post Market Quality Assurance

Job Location(s)

Bloomington IN United States

Job Locations

US-IN-Bloomington | Australia-QL-Eight Mile Plains | IE-Limerick | DK

Position Type

Full Time

Company

Cook Inc - Bloomington

Category

Quality

The Director of Post Market Quality Assurance (PMQA) is responsible for ensuring the effectiveness and compliance of complaints, adverse event reports, recalls, and related post market processes within the global corporate quality management system. This role provides leadership and direction to global Quality Assurance teams by inspiring international teams, fostering a culture of collaboration, accountability, and high performance to ensure consistent delivery of centralized capabilities across all markets, leading to positive customer experiences.

• 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.

• 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. ISO13485 and regional regulations for PMDA & TMG, MFDS, TFDA, US FDA, EUMDR, NMPA & SHMPA, and other health authorities desirable.
• 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.