Manager, Quality Assurance, CMEU

The primary responsibility of Manager, Quality Assurance, Cook Medical Europe Ltd. (CMEU), is to ensure that the Quality Management System (QMS) for CMEU meets Cook Group and relevant external regulatory requirements. This includes ensuring that the QMS is implemented, maintained and understood by all employees within CMEU.

Reporting to: Director, Quality Assurance

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• Ensure that the QMS for CMEU meets all relevant regulations including ISO13485, 93/42/EEC, Medical Device Directive, FDA 21 CFR Part 820 Quality System Regulations, Regulation (EU) 2017/745 (EU MDR), FDA 21 CFR Part 11 Electronic Records/Electronic Signatures and FDA 21 CFR.
• Ensure compliance of the QMS for CMEU with global QA policies, procedures and direction.
• Management representative for CMEU.
• Ensure that processes needed for the CMEU QMS are documented.
• Report to top management on the effectiveness of the QMS and any need for improvement.
• Ensure the promotion of awareness of applicable regulatory requirements and QMS requirements throughout the organization.
• Manage the team with overall responsibility for ensuring that the QMS for CMEU is implemented, maintained and understood by all employees within CMEU, whilst meeting all relevant external regulatory requirements.
• Manage, as appropriate for this team, activities such as hiring, promotions, transfers, and training and development, including providing regular direction, feedback and corrective action on performance, preparing and delivering annual performance and salary reviews for directs reports.
• Develop direct reports and wider team through ongoing coaching and mentoring for continued employee growth and team succession planning.
• Maintain overall responsibility for the performance of the CMEU QMS through management review and internal audits; proactively communicating the effectiveness of the QMS and any need for improvement to all relevant stakeholders and executive management and taking action to correct any identified deficiencies in a timely manner.
• Maintain overall responsibility for the CAPA and NCR systems for CMEU, issuing corrective and preventive actions in relation to non-conformities as required, and monitor effectiveness of same.
• Maintain overall responsibility for the customer complaints process, ensuring that customer complaints are dealt with appropriately by the Customer Relations team and transferred to the relevant manufacturer within agreed timelines.
• Assist with field safety corrective actions within Europe, communicating with customers and Competent Authorities.
• Responsible for the generation of Management Review reports.
• Preparation, execution and analysis of related quality documentation.
• Work closely with stakeholders in CMEU to ensure quality metrics are met or exceeded facilitating / leading interdepartmental meetings as appropriate to resolve any issues.
• Monitor trends and analyse key Quality Metrics.
• Maintain overall responsibility for managing internal and external regulatory audits, perform internal and external quality audits as required and perform Supplier Audits where necessary.
• Manage quality costs and ensure a full understanding of departmental expenditure and budget.
• Work collaboratively with the relevant business stakeholders, vendors and functional groups on new business opportunities, projects and improvement initiatives. QA representative on any relevant projects / meetings / events within CMEU.
• Maintain strong links with the Quality Assurance community within Cook Medical. Contribute and work as part of the local management team to help create a synergistic and cohesive environment.
• Act as a Continuous Improvement advocate, working with the Continuous Improvement Team, driving Continuous Improvement philosophy and practices
• Delegate for Global Director, Quality Assurance, Customer Support and Distribution for Quality related processes.
• Delegates for this position are Coordinator Customer Relations, EMEA, and Quality Assurance Engineer.
• Ensure adherence to pertinent Quality and Regulatory requirements and to departmental policies, practices and procedures.
• Ensure that Cook Medical’s Code of Conduct is considered in all business matters carried out on Cook Medical’s behalf.

• 7-plus years of applicable experience in a quality environment
• Minimum of 3 years’ management experience leading Quality professionals.
• Bachelor’s degree or equivalent in Quality, Science or Engineering.
• Knowledge and experience of ISO13485, MDD, EUMDR 2017/745 , and other applicable regulations to EMEA region desirable.
• Knowledge and experience of FDA QSR including 21 CFR Part 820 and CFR Part 11, 93/42/EEC, Medical Device Directive, GMP, and International Quality Requirements, desirable.
• Knowledge and experience of all aspects of Quality Assurance, Quality Engineering and Regulatory Affairs.
• Excellent communication and inter-personal skills.
• Excellent analytical, problem solving and organisational skills
• Excellent collaboration and interpersonal skills, with a track record of developing strong working relationships globally and with business partners.
• Ability to work constructively in a matrix-management structure.
• Willingness and availability to travel on company business.