Staffline Ireland is currently looking for a Quality Engineer. Our client is an innovative medical device company based in Galway and due to exciting growth they now have an immediate requirement for a Quality Engineer. The ideal candidate would be responsible for providing the company with technical and quality resources to manage the quality deliverables on projects, coordinating the necessary activities for ensuring the timely closure of internal/external quality issues and ensuring an effective quality system.
- Demonstrates skill in data analysis techniques to identify trends, enable data driven conclusions and act where appropriate.
- Applies problem-solving skills in order to deal creatively with complex situations, work that typically requires processing and interpreting, more complex, less clearly-defined issues. Identifies problems and possible solutions and takes appropriate action to resolve.
- Support Quality and Validation activities for product transfers and new product introductions.
- Responsible for ensuring conformance with current equipment, process, and systems validation regulations.
- Determine the implications of validations upon; Product Quality, Patient Safety, and Data Integrity.
- Assess effectiveness of measurement tools, destructive tests, non-destructive tests (measurement system analysis).
- Determine process inputs and factors for variation where process capability is required.
- Responsible for conducting (where appropriate) Installation, Operating and Performance Qualification (IQ,OQ, PQ)s.
- Develop pFMEA documentation to support processes as part of Validation process
- Ensure all activities comply with GMP, ISO and quality system requirements.
- Degree in Science, Engineering or a related Discipline
- Two years' experience in a medium to high volume manufacturing environment
- Ideally one year in a similar capacity in a regulated industry (i.e. FDA/ISO)
- Pro-active attitude, excellent organization skills, and ability to manage multiple projects while delivering results on time.
- Proficient with Excel, Power Point and ability to navigate web based applications.
- Competent working knowledge of recognized Quality Management Standards (e.g. ISO9001/ ISO13485/ ISO14971/ GMP), with a strong awareness of relevant laws and regulations (e.g. CE/ FDA/ PAL)
Why use Staffline? We know that finding the right job can be challenging and we have the tools and resources to help you succeed. An established recruitment agency since 1983, we offer permanent and temporary job solutions to lots of different clients in multiple industry sectors in Northern Ireland and Republic of Ireland. For further information please contact 091423293 or email firstname.lastname@example.org or apply with your up to date CV by clicking the button