Quality Engineer II
Location: Galway, Ireland 

An exciting opportunity has emerged with our Client, a leading medical device manufacturer in the West of Galway. Reporting to the Quality Manager, this is a permanent position that offers a competitive salary and package and the opportunity to be a key member of the QA team and lead more junior staff members.

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.
• 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.

Requirements

• 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.
• 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.
• Must be able to work under own initiative, with minimum supervision

 

For further information on this role in please contact Lisa Lawlor on 0868395533 or email stem@hero.ie

Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/

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