QUALITY ENGINEER II
Join us as a Quality Engineer II to uphold top-tier quality standards for medical devices. Your key responsibilities include documenting customer requirements, ensuring compliance, leading investigations, and driving continuous improvements. With a Degree/Diploma in Engineering, Science, Quality, or related experience, along with 5+ years in a similar role, you'll excel. Your knack for people management, attention to detail, and expertise in regulatory standards will shine. Let's make quality excellence our shared goal apply now!
- 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, CHRs, 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.
- Adhere to Plant Safety requirements and Health & Safety requirements relating to your work, assuming responsibility for those aspects of the OH&S System over which you have control to ensure the health and safety of yourself and others.
- Be aware of the potential environmental impacts associated with your work and the implications of non-conformance.
- Contribute to enhanced energy performance by conservation of energy where possible (Lighting, Equipment, Air Conditioning etc).
- Contribute to the continual improvement activities of the OH&S, Environmental and Energy Management systems through participation, providing feedback/ suggestions for improvement and by reporting accidents, dangerous occurrence, near miss/ illness, good catch and environmental incidents in a timely manner.
- 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 role in Galway please contact Katie Kilbane on +353 86 1283368 or email email@example.com Check out all our open jobs on our HERO Recruitment website https://www.hero.ie/
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