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Contact Info
James Cassidy
Life Science

+353 1 5079250
[email protected]
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Details

Quality Systems Engineer


Reference:JCA021010 Location: Westmeath
Qualification:DegreeExperience:3-4 Years
Job Type:PermanentSalary: Not Disclosed

Our client a medical device multinational currently seeks a Quality Systems Engineer t ojoin their team. The Quality Systems Engineer is a key contributor to the overall Quality Systems requirements for global QA Logistics and Distribution. They are essential in and responsible for improving and maintaining the quality management system (QMS) in line with ISO13485, 21CFR 820, Medical Devices Directive and regulatory requirements applicable to the quality management system.


Role/Responsibilities:

• With the support of subject matter experts (SMEs), drive investigations, perform robust root cause analysis, develop and implement corrective actions and establish effectiveness monitoring plans.

• Serve as a resource to NC/CAPA investigations for conducting root cause analysis and developing and implementing corrective action plans.

• Represent the Global QA L&D team at key review meetings.

• Work closely to build effective relationships with other functions in particular Supply Chain, Operations, IT and Regulatory teams.

• Quality system compliance to EN ISO, MDSAP, 21CFR 820, Medical Devices Directive, Medical Device Regulation, and other regulatory requirements applicable to the QMS.

• Identify and implement opportunities for improvements.

• Actively coach the L&D organization to support the effective implementation and maintenance of a compliant quality management system, including applicable QS Elements; NC, CAPA, Management Review etc.

• Provide Quality Systems support to all areas of the L&D QMS ensuring compliance is maintained at all times

• Proactively lead/participate in Global QA L&D Improvement Projects


Skills / Experience:

• Third level Engineering/Science degree or equivalent

• A minimum of 5 years experience within the Medical Device industry, specifically in a Quality environment

• Lead Quality Auditor Certification preferrable

• Experience with notified bodies and regulatory authorities

• Working knowledge of requirements e.g. MDR, FDA, ISO

• Excellent analytical ability and technical writing skills • Attention to detail and accuracy • Ability to work well under deadlines and pressure

• Communication skills and Problem solving skills for developing creative solutions and meeting objectives are required, ability to interface with all levels of management.

• Skills that enable coordination of data, including MS-Office (primarily PowerPoint, Word, MD Project, Outlook and Excel)

• The ability to prioritize tasks and be able to manage several projects and tasks simultaneously. Confidential

• Ability to establish and maintain effective working relationships within the QA L&D department and with all levels of the businesses.

• Ability to gain the confidence, respect and trust of management and staff through attributes such as professionalism and positive attitude.

• Be approachable, enthusiastic, flexible and adaptable.

• Able to work on their own initiative and as a team player.

• Excellent organisational skills with cultural awareness and sensitivity.