Our client a Major Multinational here in Galway are looking to hire a Senior Quality Engineer, Post Market, Complaint Investigations. This role is permanent offering a range of benefits.
- This role is focused on the execution of insightful complaint investigations to meet the requirements of the Quality Management System, the specific requirements of Post Market Quality Assurance, and established annual objectives.
- Demonstrates commitment to the company Quality Policy (patient safety and product quality) through daily execution of sound quality practices and the maintenance of an effective quality system.
- Understands and complies with all the regulations governing the quality systems.
- Leadership for the execution of investigations applicable to product complaints and completion of investigation records within the Global Complaints System Management system.
- Provides direction and guidance for assigned tasks to meet department goals and objectives to direct reports, ensuring that investigations applicable to product complaints and related records within the Global Complaints System Management system are robust, with insightful conclusions that support product performance improvements.
- Ensures direct reports are aware of their commitment to patient safety and product quality, are current with training requirements and that they understand and comply with all other regulations governing their work.
- Ensures the execution of applicable analysis on returned product samples using available methods/equipment and applying problem-solving and investigation skills. Makes solid and consistent Engineering and Quality Assurance recommendations.
- Demonstrates and actively promotes the highest levels of professional QA engineering discipline and rigor including reverse engineering methods to provide insightful conclusions on product performance.
- Seeks and drives continuous improvement initiatives to investigate methodology and associated processes and lead applicable projects of improvement.
- Make decisions and determines escalation pathways, as well as demonstrate the ability to work on one’s own initiative and with minimum supervision is required.
- Ensure the preparation and provision of complaint trend data to internal customers and sharing of complaint data and trend analysis at applicable review forums.
- Development and maintenance of collaborative relationships within the team and with other CIS centers and Complaint Management Centres (CMCs) across the Post Market Quality Assurance function.
- Development and maintenance of partnerships with Quality Operations, Design Assurance, and R&D for the execution of insightful investigations and to support product performance improvements.
- Works with EHS to identify significant environmental impacts of company operations and to establish goals and targets around significant environmental impacts.
- Deals with suppliers, other engineering disciplines within and outside of the Site, and customers should the need arise.
- Ensure compliance with company policies and procedures (e.g. compliance with FDA, BSI, EEO regulations, etc) and promotes awareness of best industry practices by making appropriate decisions with the CIS Quality Manager / Site QA Director as final arbitrators on critical quality decisions.
- Works actively to ensure compliance with laws, regulations, and regulatory directives of all geographies where the company does business. Facilitates as required both internal and external audits.
- HETAC Level 8 qualification in a STEM subject.
- 6-8 years of relevant work experience.
- Strong technical capabilities, communication skills, and organization skills, ideally with experience of people management and/or team development.
- Demonstration of problem-solving, process improvements, and/or project management skillsets and application and proven ability to take initiative to drive improvement and change.
- Knowledge of product design, manufacture, functionality, and/or clinical use environment. Experience in Structural Heart product design or manufacturing and/or Angiographic image review experience would be an advantage.
- Experience in laboratory controls, equipment sourcing, and validation would be an advantage.
- Hepatitis B Vaccinations course for the returned decontaminated products.
- Ability to travel occasionally for applicable assignments or meetings.
For more information or a confidential discussion about this role please contact Michelle Mc Inerney.
091 706 717