Telephone: 086 8395533
Senior Quality Engineer (12 - 18 Month Contract)
The Senior Quality Engineer is a key member of our clients Integration Project Team who works closely with the Project Leader to ensure successful knowledge transfer, development and implementation of a FDA & ISO13485 approved Quality System.
- This position is as a key point of contact within the integration team for all elements related to Quality.
- Acts as a key conduit for access to existing Neurovascular related resources, systems (e.g. PDM, Trackwise), processes and procedures.
- Interfaces with critical NV business users and Quality System Subject Matter Experts (SMEs) to gather required information to support the development & implementation of the Quality Management System (QMS).
- Responsible for providing Quality expertise and decision making in developing and implementing our clients NV QMS. As required, leads sub-teams tasked with the achievement of specific project goals.
- Participates in cross-functional workshops and meetings involved in the development and execution of MIS (MES/ERP) test scripts and training plans.
- Ensures that all systems, processes and procedures developed are in compliance with FDA QSRs & ISO requirements and are best suited to deliver to NV customer needs. Is the Quality SME for the review and approval of documents related to the QMS as required (e.g. Validations, Procedures)
- Engages with transferring employees within the manufacturing/ Value Stream Teams to complete documentation/ procedures and support all training requirements.
- Performs internal and third party (Supplier audits) as and when necessary as part of the development of our clients NV QMS.
- Assists in the development of QMS metrics for the Cork NV site.
- Adheres to all Health and Safety procedures and requirements.
Education, Experience & skills:
- Engineering/Quality or Science related Degree essential. Completion of an external Quality Assurance related course desirable.
- Minimum of 7 years experience in a quality engineering role within a high volume manufacturing environment. Two years experience within a medical device environment required with NV Quality System knowledge an advantage.
- Excellent project management capabilities: plans, prioritizes and organizes multiple concurrent tasks to meet deadlines.
- Communicates and influences at different forums, functions and levels within the local Ireland sites and in Divisional/ Corporate arenas.
- Builds strong relationships by fostering open communications, respect and trust. Is diplomatic, tactful and leverages excellent interpersonal keys to help achieve outcomes.
- Can manage around obstacles and ambiguity. Is a highly effective problem solver in a changing and politically challenging context.
- Builds strong customer engagement and credibility by delivering on expectations and commitments.
- Is open to change and analyses successes and failures for continuous improvement.
- Strong Team player who effectively utilises individual strengths and talents to maximise team services to customers. Focuses on achievement of team objectives and team success.
- Ability to generate, follow and explain detailed quality requirements and inspection procedures.
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