Quality Engineering Team Lead

The primary function of this role is to lead and supervise the Quality Engineering group including Senior Quality Engineer(s), Quality Engineers and Complaint Investigator(s).

Agree objectives, generate training plans, coach team members, carry out performance appraisals and deal with performance related issues.

Assess workload for the group and allocate tasks accordingly.

Reporting to : Quality Engineering Manager

Find out more about Cook Medical here

Responsibilities

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.

Qualifications

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.

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