Job Title: Quality Engineer II
Kelly Services have partnered with an exciting client to recruit a Quality Engineer II to join their team at their Galway location. The Quality Engineer will have excellent communication skills with good working knowledge of applicable regulatory requirements in the medical device industry.
This is a great opportunity to join an expanding, global team.
- Ensure all customer requirements are identified, clearly documented in company 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 company 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 and validated in accordance with customer and company requirements. Write validation protocols, reports and test report 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
- Work with customers and suppliers on quality related issues and NPI projects
- 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 staff
- Excellent attention to detail
- Good working knowledge of applicable regulatory requirements (ISO 13485, FDA etc.)
- Proven track record in problem solving. Six Sigma qualification (Green Belt or higher) required
- Understanding of lean principles. Lean green belt an advantage
- A positive attitude in dealing with people
- Ability to learn and adapt to various situations
- Must be able to work on own initiative, with minimum supervision
Kelly Services are acting as an Employment Agency in relation to this role. Should you choose to apply, your information will be processed in accordance with Kelly’s Privacy Statement. For information regarding data protection at Kelly, please visit the Kelly website and have a look into the Privacy Statement.
As an Equal Opportunities employer we welcome applications from all suitably qualified persons regardless of their race, sex, disability, religion/belief, sexual orientation or age.