Quality Engineering Team Lead

• Drive all assigned Quality Engineering projects and ensuring that they are managed in a structured fashion and completed in compliance with the relevant procedures.
• Manage and drive project activities to ensure timely completion of project milestones.
• Represent team at key review meetings.
• Work closely to build effective relationships with other functions in particular Operations, IT, Engineering and Regulatory teams.
• Leading the area of FDA, QSR and ISO13485 requirements, promoting, awareness of best industry practice and making appropriate decisions on a daily basis using the Quality Engineering Manager as the final arbitrator on critical quality decisions.
• Identify and implement opportunities for improvement.
• Maintain a proactive approach to developing Cook’s Quality system to meet the changing needs of the business.
• Ensure that in-house or external Quality issues are effectively prioritised and acted upon in a timely manner.
• Responsible for Quality systems including the following key processes within the Quality Engineering group:

• Design, Process and Software Validation.
• Supplier Quality.
• CAPA.
• Non conformances.
• Customer Complaints
• Support of the Internal Audit, Supplier Audit and Regulatory Audit Programmes.
• Prepare execute and analyse Quality Engineering Documentation.
• Trending and analysis of key Quality metrics.
• Responsible for the assessment of risk throughout Quality Engineering key processes and systems.
• Provide leadership and mentoring to team members to ensure the effective completion of activities associated with their role.
• Designee for the Quality Engineering Manager.
• The Quality Engineering Team Leader signature is equivalent to Senior Quality Engineer.
• Ensure that Cook’s Code of Conduct is considered with in all business matters carried out on Cook’s behalf.

• Third level qualification in Science, Engineering or relevant technical discipline.
• Proven knowledge and experience (ideally minimum 6 years) of working with ISO13485, ISO14971, the Medical Device Directive, EU Medical Device Regulation 2017/745 and the FDA QSR including 21 CFR Part 820 and 21 CFR Part 11, ideally gained in the medical device industry.
• Previous supervisory experience would be beneficial.
• Excellent communication and inter-personal skills.
• Proven track record of perusing continuous self-improvement.
• Good working knowledge of Microsoft Office.
• Proven Problem-Solving Skills.
• Good working knowledge of statistics.
• Knowledge and experience of all aspects of validation.
• Excellent organisational, time management and presentation skills.
• Excellent attention to detail.
• Proven self-starter
• Willingness and availability to travel on company business.

Cook Medical