Quality Team Lead

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Title: Quality Team LeadLocation: O'Halloran road, LimerickBenefits: Salary, pension, healthcare and yearly bonus OverviewThe 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.ResponsibilitiesResponsible 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 ensures 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.Supplier QualityComplaint InvestigationCorrective Action Preventive Action (CAPA)/ Supplier Corrective Action ( SCA)Non Conformances (NCR)Statistical AnalysisHealth Risk AssessmentField 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. QualificationsThird 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.Would you be interested in hearing more about this opportunity? If so forward your up to date CV or email/ Call me to discuss further, happy to answer any questions. Look forward to hearing from you. To find out more about Real please visit www.realstaffing.comReal Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales