Quality Engineer II
Quality Engineer II
My client is a highly sought after Medical Device company in the West of Galway has a new opportunity for a Quality Engineer to join on a permanent basis.
This role will form part of the Quality Assurance Team. The primary objective of the role is to ensure products are manufactured in accordance with customer requirements and the requirements of the Quality Management System.
Duties and Responsibilities
- Ensure all customer requirements are identified, clearly documented in manufacturing documentation and effectively implemented.
- Ensure the Quality System is fully compliant with customer and regulatory requirements.
- Ensure that incoming, in-process and final inspection plans are adequate and regularly reviewed for effectiveness.
- Investigate product/process quality issues that arise, including customer complaints. Ensure they are effectively resolved in a timely manner using the CAPA system.
- Assess all product and manufacturing related changes, deviations and reworks, for their impact on validations, product quality and the customer.
- Make product dispositions as and when required. Update documentation such as specifications and visual standards to better define the quality characteristic being dispositioned.
- Ensure processes are validated in accordance with customer and Quality System requirements. Write validation protocols, reports and test reports as required.
- Act as a Lead Quality Auditor. Perform Supplier Quality Audits. Act as a guide during customer and regulatory audits.
- Document manufacturing procedures, CHR’s, purchasing specifications, inspection procedures and standards. Review and approve all updates to same.
- Use process data such as yield, output rates etc. to identify opportunities for improvement. Implement improvements on an ongoing basis.
- Supervise the activities of assigned staff.
- Work with customers and suppliers on quality related issues and new product introduction projects. Ensure all dealings are professional and good relationships are maintained at all times.
- Be part of project teams. Deliver on commits to schedule and budget.
- To take on other duties which the Company may assign you from time to time. These ‘other duties’ will be agreed with Management prior to any assignment.
- Degree / Diploma qualification in Engineering, Science and/or Quality or relevant experience in a quality assurance role within the Medical Device Industry.
- A minimum of 5 years experience in a similar role.
- Good people management skills. Must be able to manage a team of upto 4 staff.
- Excellent attention to detail.
- Good working knowledge of applicable regulatory requirements (ISO 13485, FDA etc.)
- Proven track record in problem solving. 6 sigma qualification (Green Belt of higher) required.
- Understanding of lean principles. Lean green belt an advantage.
- Excellent communication skills both verbal and written.
- A positive attitude in dealing with people.
- Ability to learn and adapt to various situations.
- Must be able to work under own initiative, with minimum supervision.
For further information on this Quality Engineer role in Galway please contact Clara Burke on 086 8168273 / email@example.com
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