Job title:Senior Design Assurance Engineer
Location:Parkmore Business Park, Galway.
Benefits:Excellent salary, bonus, pension, healthcare, hybrid working and opportunity to grow your career with hugely exciting Medical Device organisation.
Company:
My client are an early stage Irish MedTech company located in Galway, a global centre for excellence in medical technologies. The company collaborates with clinicians and research institutions across the world developing and commercialising a new technology platform for endovascular surgery that will focus initially on patients with Critical limb ischemia.
About the role:
As a Senior Design Assurance Engineer is to be the QA technical and compliance expert as part of a cross functional team for the design and development of sterile medical devices and /or subsequent modifications thereafter in compliance to current Regulatory requirements i.e. ISO 13485, CFR 820 and governing Regulatory Standards associated with the product classification. Lead the following activities from a quality perspective:
• Risk Assessments
• Device testing and associated validations
• Audits i.e. Critical Suppliers, Self-Inspections,
• On-going continuous improvement of the QMS
• Generation and /or approval of technical documents on behalf of the Quality Function.
Responsibilities:
- Responsible for compliance of product development and risk management activities with Medical Policies and Procedures and applicable Governing Regulatory Requirements.
- Work effectively as part of product development team in identifying and translating user requirements into design requirements, identifying critical design features and components, and contributing towards or leading the generation of risk management documents and associated quality documents, reports etc .
- Complete design verification, design validation and test method validation activities associated with product development activities.
- Works with R&D and Manufacturing Engineering in translating design requirements into manufacturing requirements, including the development of manufacturing test methods and implementation of appropriate production process monitoring activities.
- Support the resolution of 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.
- Monitors compliance with Medical policies, procedures and applicable regulatory requirements, identifying, reporting and implementing process and system improvements.
Requirements:
- Minimum Bachelor's Degree in Engineering, Science or related technical field.
- 4+ years minimum QA, Quality System or regulatory experience in the medical industry a prerequisite. Ideally includes a minimum of 1 years in the QA activities associated with product design and development.
- Knowledge of FDA's 21 CFR Part 820 (Quality System Regulation), ISO 13485:2016,the European Medical Device Regulations, the Canadian Medical Device Regulations and other international standards and regulations.
- Results and deadline driven with an ability to handle multiple tasks and operate in a fast paced environment..
Does this sound like your next career move? To apply and For more info forward your application to the link provided or contact me on 087 0612325 OR [email protected]
