The primary function of this role is to manage the Quality Engineering Post Market Surveillance group which is comprised of the Regulatory Communications and Complaints Investigation (including post market Quality Engineering) teams. Responsibilities will include agreeing department and individual objectives, generate training plans, coaching team members, carrying out performance appraisals, dealing with performance related issues and assessing workload for the group and allocate tasks accordingly. Develop and Manage Quality Engineering Post Market Surveillance requirements in line with Corporate and Industry best practice
Reporting to: Senior Quality Engineering Manager
- Responsible for supervising the day to day workload and operational issues of the quality engineering PMS 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 team members to complete assigned tasks.
- Fosters accountability within the team to meet established timelines.
- Mentors and trains new team members.
- 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 PMS Department.
- Driving all assigned Quality Engineering PMS projects and ensuring that they are managed in a structured fashion and completed in compliance with the relevant procedures.
- Promoting awareness of best industry practice and making appropriate decisions on a daily basis using the Senior Quality Engineering Manager as the final arbitrator on critical quality decisions.
- Maintaining a proactive approach to developing Cook’s Quality system to meet the changing needs of the business.
- Provide meaningful Quality measurement while ensuring 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 PMS group:
- Complaint Investigation
- Regulatory Communications
- Field Action
- Support inputs into the Post Market Surveillance Programme.
- Support of the Internal Audit, Supplier Audit and Regulatory Audit Programmes.
- Managing quality engineering PMS support and input to other departments within Cook Medical including Regulatory Affairs, Quality Assurance, Operations and Engineering.
- Represent Quality Engineering PMS at a Global level and participate in working groups to drive improvements to Quality Engineering Systems.
- Preparation, execution and analysis of related Quality Engineering PMS Documentation.
- Responsible for the generation of Management Review Reports.
- Trending and analysis of key Quality metrics.
- Responsible for the assessment of risk throughout our key processes and systems.
- Delegate for the Senior Quality Engineering Manager
- Delegate for this position is the Quality Engineering Team Lead
- Ensure that Cook’s Code of Conduct is considered with in all business matters carried out on Cook’s behalf.
- Degree in Quality, Science, Regulatory Affairs or Engineering is required.
- Proven knowledge and experience (min 7 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.
- Experience in regulatory reporting and field action is essential.
- Proven Supervisory experience and skills.
- Exposure to Lean Manufacturing, with Six Sigma green or black belt would be an advantage.
- Excellent communication and inter-personal skills.
- Good working knowledge of Microsoft Office.
- Proven Problem-Solving Skills.
- Excellent organisational skills.
- Highly Self Motivated and dependable
- Excellent decision maker.
- Willingness and availability to travel on company business.
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