Location:

Connacht

Qualifications:

Degree

Experience:

2-3 Years

Job Type:

Permanent

Salary:

Negotiable

Consultant:

James Cassidy

Quality Engineer

Reporting to the Quality Manager, the successful candidate will be a highly motivated, enthusiastic individual, educated to degree / diploma level in Quality Assurance related discipline. Must have a proven track record of at least three years experience in Quality Systems Maintenance and Development, with Medical Device exposure preferred. Must have the ability to work within the QMS with minimum supervision.
The successful candidate will be expected to contribute significantly to the future development and maintenance of the QMS. Applicants should be familiar with concepts of ISO Quality Standards, with a knowledge of ISO, MDD, FDA requirements.

Responsibilities / Duties:
- Head up the Quality Engineering element of the existing product base
- Perform process control monitoring & improvement activities
- Be part of a cross functional team involved in new product introductions w.r.t Quality
- Work & report on CAPA, vendor CAPA, MRB, customer complaint activities
- Interact directly with vendors and customers
- Perform and provide support to validations, metrology, document control, internal auditing
- Provide input from a quality perspective to product & process risk assessments, pFMEA
- Have overall responsibility for GMP compliance in working area
- Ensure environmental monitoring is performed and reported on in a timely manner
- Liaise with other departments as required as part of day-to-day activities

Requirements:
Third level qualifications in Quality, Engineering, Science or related discipline.
Minimum 3 years in a similar role in the medical device industry advantageous
Knowledge of ISO, MDD, FDA important
Demonstrated track record in a similar role
Excellent attention to detail and accuracy
Excellent oral & written communication skills

For immediate consideration please contact James Cassidy at 01-6854545