Our Client is a Medical Device company based in Galway. They are currently looking for a Design Assurance Engineer to join their team. 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 company 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 verification, design validation and test method validation activities associated with product development ang 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 company policies, procedures and applicable regulatory requirements, identifying and implementing process and system improvements.
• Leads and/or facilitates compliance and improvement activities associated with the company 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.
ESSENTIAL SKILLS/ EXPERIENCE:
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.
KEY RELATIONSHIPS/ INTERFACES: Regulatory, R&D, Clinical, Marketing, Operations, Distribution, External Services Suppliers
Strong work ethic, combined with creativity, initiative and great technical capability. Excellent presentation and verbal communication skills are essential.
Clodagh Nerney | Tel: +353 (0) 1 507 9254