Quality Engineer-Operations
Reference: | JCA02106 |
Location: |
Galway
|
Qualification: | Degree | Experience: | 2-3 Years |
Job Type: | Permanent | Salary: |
Not Disclosed |
Quality Engineer – Operations
Our client a high potential and fast growing medical device start up currently seeks a Quality Engineer to join their team. The Quality Engineer will work as part of the Quality and Regulatory Affairs teams and be responsible for tasks supporting the Operations function.
Role/Responsibilities:
- Liaise with technical operations function to support the inspection and manufacturing activities at the OEM facility to ensure compliant product is consistently delivered.
- Develop and implement inspection procedures for incoming components, in process assemblies and final product and manage and co-ordinate all inspection activities.
- Manage and implement procedures for non-conforming product.
- Develop and maintain PFMEA and provide direction in the development of validation protocols and reports.
- Review DHR records and prepare product release documentation.
- Prepare quality system metrics on a pre-determined basis to support management meetings and for management review.
- Implement the CAPA system at ensuring that comprehensive root cause analysis is completed and that corrective and preventive actions are effectively implemented.
- Support the supplier management programme ensuring that all sub-contractors, suppliers, and external parties meet and adhere to the requirements of the quality system.
- Support the continuous improvement of quality system processes and the business generally.
- Complete tasks as designated by your supervisor to support the needs of the business.
Skills/Experience:
- Bachelor’s degree in Science or Engineering is a pre-requisite for this role.
- A minimum of two years experience in a quality engineering or regulatory role ideally in a regulated environment. Medical device industry experience is an advantage.
- A self-starter who can see and deliver the work required to advance the company goals with a minimal amount of direction.
- Excellent written, interpersonal communication and presentation skills.
- Holds him/herself and others accountable to meet commitments by following through, acting with a clear sense of ownership, and taking personal responsibility for decisions, actions and failures.
For further information contact James Cassidy [email protected] of call in confidence 0860204322