Our client, a leading medical device company in Galway, is hiring a Quality Assurance Engineer II.
Responsibilities include but are not limited to the following:
* Ensure all customer requirements are identified, clearly documented in the Company’s 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 are validated in accordance with customer and Company Medical 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 the 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 commitments 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 occurrences, near misses/illness, good catches, 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.
Job 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 up to 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 or higher) required.
* Understanding of lean principles. Lean green belt is 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.
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