Description
About the Company:This award winning company has a huge presence in Ireland. It is an exciting growth phase for this organisation and there are presently major expansion operations underway. Being part of this organisation at this time will provide you with a sense of achievement and opportunity to really make an impact.
Job Purpose:
Reporting to the Head of Quality and Technical Affairs, the successful candidate will be responsible for providing guidance on all aspects of quality, validation and quality engineering within a cross-functional team thus ensuring customer satisfaction and reduction of scrap.
Principal Duties and Responsibilities:
The main duties include but are not limited to the following:
- Support Operations through the product life cycle / process for defined product portfolios
- Management of process deviations, non-conformances, reworks, CAPA, Design Changes, complaints, scrap and change requests for product group
- Lead Validation activities for designated product groups
- Conduct process and GMP audits and ensure area compliance
- Liaise with regulatory department to ensure product supply is maintained and all quality aspects are met
- Champion QA and continuous improvement initiatives
Qualifications, Skills and Behaviours:
The ideal candidate will be highly motivated, dynamic and a goal achiever that has:
- Graduate in a science, engineering or related background
- Minimum 5 years in a QA Engineering / QE role, working within a recognised quality system within IVD, Medical Device or Pharma industry
- Minimum 3 years validation experience in equipment/process/software is highly desirable.
- A working knowledge of regulatory requirements
- A technical background or knowledge of IVD products or Medical devices would be advantageous
- Awareness of statistical techniques and validation
- Experience of internal, third party regulatory & external customer audits
- A high degree of computer literacy
- The ideal candidate should demonstrate a logical and planned approach to all tasks
- Excellent written, oral and communication skills
- Be a team player and have high personal confidence, ability to liaise with other business divisions
- The ability to work in a multi-disciplinary team environment
- Ability to work on their own initiative
- Be customer-focused
- Have a high attention to detail
- Be flexible and willing to carry out overtime as necessary when required
- Be conscious of Health & Safety requirements at all times