Cook Medical are currently seeking an experienced Senior Quality Engineer to join their Quality department.
· Leading and supervising the Quality Engineering/Systems group including Quality Engineer(s) and Quality Technician(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.
· Driving all assigned Quality projects and ensuring that they are managed in a structured fashion and completed in compliance with the relevant procedures.
· Leading in the area of FDA QSR and ISO13485:2003 requirements, promoting awareness of best industry practice and making appropriate decisions on a daily basis using the Quality and Regulatory 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 group:
o Process and Software Validation
o Supplier Quality
· Deputising for other Quality / Regulatory positions including Regulatory Specialist/Microbiologist and Software Quality Engineer as required.
· Managing quality engineering support to other departments within Cook Medical including Operations and Product Development.
· Performing internal and external quality audits.
· Preparation, execution and analysis of related Quality Engineering Documentation.
· Trending and analysis of key Quality metrics.
- Responsible for the assessment of risk throughout our key processes and systems.
- Designee for the Quality and Regulatory Affairs Manager.
- Responsible for supervising the day to day workload and operational issues of the Document Control team, labeling and CAPA co-coordinator. 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.
- Co-ordinate the day to day running of the Cook Medical Document and Labelling Control areas, IFU and CAPA programmes in accordance with internal procedures and regulatory requirements.
- Responsible for the Cook Medical Corrective and Preventive Action program (CAPAs).
- Responsible for the Cook Medical Non-conforming process, (NCR’s).
- Ensure that Cook’s Code of Conduct is considered in all business matters carried out on Cook’s behalf.
- Third level qualification in Quality, Science or Engineering
- Proven knowledge and experience (min 4 years) of working with ISO13485:2003, ISO14971: 2000, the Medical Device Directive and the FDA QSR including 21 CFR Part 820 and 21 CFR Part 11, ideally gained in the medical device industry.
- Excellent communication and inter-personal skills.
- 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 skills.
- High Self Motivation
- Availability and willingness to travel on company business.