Description
One of our clients, a leading medical device company based in Galway, have an opening for a Quality Engineer. The successful candidate will be required to have a high level of NPI experience.You will be working on new lines, validating them and bringing them to production, ensuring each line is running effectively. A good knowledge of quality systems and ability to identify problems and dealing with them.
Responsibilities
- Work closely with customers to establish / confirm specification for new products.
- Work with Process Engineers to establish required documentation such as manufacturing routes, purchasing specifications, inspection procedures, criteria etc.
- Generation of Master Validation Plans, FMEAs, IQ/OQ/PQ protocols and reports.
- Ensure compliance to validation plans(s), work to ensure adherence to project timelines.
- Preparation of work instruction post validation activities.
- Review / audit compliance to procedures.
- Review line issues and work with the team in resolving line issues and implementing corrective actions.
- Review customer request / complaints.
- Raise CAPA's as required, manage timely resolution of issues.
- Carry our internal audits and prepare for internal / external / customer audits.
- General quality systems management activities.
- To take on other duties which the Company may assign you from time to time. These will be agreed with
Requirements
- Degree qualification in Engineering / BSc / Quality Systems is required.
- A minimum of 5+ years' experience in a similar role in the Medical Device / Component Industry.
- Excellent communication skills with ability to write reports, summaries and reporting what stage correcting issues are at.
- Experience in dealing with new products and customer complaints
- Excellent knowledge of product and ability to explain them in detail
- Ability to learn and adapt to various situations.
- Excellent knowledge of Quality Systems
This is an excellent opportunity to join our client during an exciting growth period for the company. This expansion will lead to further opportunities for career progression.
The successful candidate will be very hands on who will control their lines and be proactive in dealing with issues.
A salary of €40,000 to €50,000 with an excellent benefits package is on offer. Apply now for immediate consideration or contact Derek Sheridan on 01 888
To find out more about Real please visit www.realstaffing.com