PJ Personnel currently seek a Quality Assurance Engineer for a leading Medical Device Manufacturer in Galway, Ireland
- Provide Design Assurance support in assigned Operations and R&D Projects
- Initiate, develop and implement quality system improvements
- Provide support for QA system activities including audits, system reviews, and maintenance of the QMS
- Provide guidance, direction and supervision to QA Technical Staff where appropriate
- Bachelor's Degree in Engineering or equivalent technical qualification
- Minimum of 3 years' experience in a similar role/environment
- Good working knowledge of quality systems and their application in a Design/manufacturing environment
- Good working Knowledge of the Design Control Process
- Experience of statistics and a good working knowledge of test method validation
- Working Knowledge of the requirements and application of ISO14971:2012
- Good working knowledge of regulatory standards and industry practices for Medical Device Manufacture
Candidate should also have the following abilities/skills/qualities:
- Ability to work under strict time constraints; meet deadlines in a timely manner with minimal guidance
- Team player: Ability to work and communicate effectively as part of QA and cross functional / organisational teams; be flexible with a 'can do' attitude
- Excellent communication (oral and written) and interpersonal skills with the ability to convey information and ideas in a variety of media, tactful, confident, at all levels, internal and external.
- Passion for data, analysis, trends, reporting. Ability to read and interpret documents. Ability to clearly and informatively write technical documentation, routine reports, correspondence, procedures and work flows. Present numerical data effectively.
- Demonstrate organisational values (Customer First, Achieving Excellence, Developing People, Flexibility and Integrity) in carrying out of all assigned responsibilities/tasks.
- PC Skills: Standard offices packages and ability to understand and learn customized computer software programmes