Description:
The successful Candidate will lead and supervise a team of Quality Technicians in both the Document Control Area and Customer Quality Group.
Responsibilities
• Leading and supervising the Customer Quality Group. Agree objectives, generate training plans, coach team members, carry out performance appraisals and deal with performance related issues.
• Group responsible for the initial logging of complaints, initial review, AE Reporting Assessment, completion of manufacturing review, liaison with QE and distribution for requests for additional information, where necessary.
• Work closely with QE group, responsible for complaint investigations and risk assessments.
• Driving all assigned Customer 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 Manager as the final arbitrator on critical complaint decisions.
• Managing customer quality support to other departments within Company including Operations and Product Development.
• Work with world wide competent authorities and notified bodies to ensure that our customer quality procedures are compliant.
• Lead and supervise the Document Control Group. Agree objectives, generate training plans, coach team members, carry out performance appraisals and solve performance related issues.
• Performing internal and external quality audits.
• Preparation, execution and analysis of related Quality Documentation.
• Trending and analysis of key Quality Metrics.
Applications are invited from candidates with the following background and experience:
• 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, Part 803 and 21 CFR Part 11, ideally gained in the medical device industry.
• Minimum of 4 years experience in a similar role at a supervisory level.
• 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
Interested candidates must be available and willing to travel on company business.
For a full Job Spec and further information please call Deirdre at 01 2784671 or e-mail your CV to dbolger@thornshaw.com
Log on to www.thornshaw.com for more jobs.
Key Words: Quality, QA, Customer service, Medical Device, Science, Engineering, Auditor,Valiidation, Ireland Jobs