We are working in partnership with our client based in the Midlands. We have a new opening for an Quality Engineer to join their growing team. Reporting to the Quality Assurance Manager, you will be the Product Quality representative working with the customer and their design and manufacturing teams on new products. This role is focused on ensuring the best product is produced to meet capacity, reliability, and design intents. This individual must have strong technical ability, problem-solving skills, and communication skills to help troubleshoot, diagnose, and solve issues during the development phases and through the start of production.
- Maintain a quality system compliant with the ISO standards ISO13485, ISO9001 & IATF standard IATF16949, and all applicable regulations under associated directives.
- Responsible for investigations into Product/Process non-conformances and customer complaints on both Medical and non-medical products.
- Perform an active role in quality planning and new product introduction.
- Ability to lead cross-functional teams in continuous improvement activities, championing a structured approach to problem-solving.
- Ability to lead cross-functional teams in managing change controls across the Plant.
- Responsible for managing Suppliers and performing internal & external audits.
- Provide training in Quality Processes and Procedures to the extended production and technical support team.
- Responsible for leading cross-functional teams in completing Product and Process risk assessments.
The Ideal Candidate will have:
- Have a relevant 3rd level qualification in Engineering or a related field
- Minimum 2-3 years experience in a manufacturing environment.
- Previous experience in an ISO13485 regulated manufacturing environment would be a distinct advantage.
- Experience with quality systems and validation would be a concrete benefit.
- Medical device manufacturing experience is desired but not essential.
- Strong attention to detail with a structured approach to planning & organising.
- Be able to work on your own initiative and priorities work as required.
- Have excellent communication skills.
If you would like more information on this role you can contact Paul Dunican
(090) 641 7022