Our client a leading medical device manufacturer in Galway is hiring a Quality Assurance Engineer.
II 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.
Responsibilities include but are no limited to the following: 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 and ensure they are effectively resolved in a timely manner using the company's 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 and 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.
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.
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.
Note: By applying for this position, you may also be considered by Pale Blue Dot Recruitment for other or future related vacancies.
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