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Design Assurance Engineer
Our client, a medical device company in Galway are currently looking to recruit a Design Assurance Engineer for their site.
This position provides QA Technical and compliance expertise as part of teams tasked with establishing customer needs, developing new products and/or modifying existing designs.
- Responsible for compliance of product development, risk management and post market activities with Policies and Procedures and applicable International Regulations.
- Work as part of product development team in identifying and translating user requirements into design requirements, identifying critical design features and components.
- Complete design verification, design validation and test method validation activities associated with product development and implementing design/process changes.
- Work with R&D and manufacturing engineering in translating design requirements into manufacturing requirements, including the development of manufacturing test methods and implementing production monitoring and controls.
- Resolve project issues by working with team members, suppliers, and others as appropriate. Apply thorough, systematic problem-solving methodologies in identifying, prioritising, communicating, and resolving quality issues.
- Monitor compliance with policies, procedures and applicable regulatory requirements, identifying and implementing process and system improvements.
- Leads and/or facilitates compliance and improvement activities associated with the quality system (e.g. CAPA).
- Demonstrate an ability to apply, recommend and/or create quality tools and apply them effectively to a variety of business situations related to product development, and post market activities.
- Minimum Bachelor's Degree in Engineering, Science or related technical field, and a 3 years minimum QA, Quality System or regulatory experience in the medical industry a prerequisite.
- The successful candidate will need a strong technical aptitude with an excellent understanding of their subject matter.
- Be highly motivated and an enthusiastic self-starter with the ability to work under own initiative and as a team player.
- Regulatory, R&D, Clinical, Marketing, Operations, Distribution, External Services Suppliers
- Required include strong work ethic, combined with creativity, initiative and great technical capability.
- Excellent presentation and verbal communication skills are essential.
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