Quality Team Lead
Job ID: JOB-11698
Quality Team Lead
A leading medical device manufacturer in Limerick is recruiting for a Quality Team Lead to join the Quality operations on a permanent basis.
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.
- Responsible for supervising the day to day workload and operational issues of the quality engineering team. This includes, but is not limited to, setting team and individual objectives, carrying out performance appraisals, generating training plans and dealing with performance related issues.
- Monitors the progress of team members on assigned tasks and removes roadblocks.
- Provides direction and logistical support to the QE team members to complete assigned tasks.
- Fosters accountability within the team to meet established timelines.
- Provide leadership and mentoring to team members to ensure the effective completion of activities associated with their role.
- Responsibility for implementing requirements in accordance with ISO13485, MDD 93/42/EEC, EU Medical Device Regulation 2017/745 and FDA QSP 21CFR Part 820 as required and other jurisdictions as required.
- Actively pursues ways in which to improve the function of the Quality Engineering Department.
- 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.
- 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.
- Maintain a proactive approach to developing the 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: o Supplier Quality o Complaint Investigation o Corrective Action Preventive Action (CAPA)/ Supplier Corrective Action ( SCA) o Non Conformances (NCR) o Statistical Analysis o Health Risk Assessment o Field Action
- 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.
- Manage quality engineering support to the company.
- Designee for the Quality Engineering Manager.
- The Quality Engineering Team Leader signature is equivalent to Senior Quality Engineer.
- Ensure that the Code of Conduct is considered with in all business matters carried out on the company’s behalf.
Qualifications / Requirements:
- 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 is essential.
- Experience with combination devices, sterilisation and/or microbiology would be advantageous.
- 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, including design, process, software and cleaning.
- 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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