Our client a major multinational here in Galway are seeking a Design Assurance Engineer II on a permanent basis to join their growing team.
The Role: Fulfil the quality assurance responsibilities of company xxxproduct development and related PTP engineering activities, including: Creating and maintaining a culture of commitment to improving patient safety, customer satisfaction and product quality.
Assuring compliance by interpreting and fulfilling regulatory requirements applicable to the medical device industry.
Promoting and effecting compliance to quality, business and health & safety systems and market/legal regulations.
Analysing, reducing and managing risks associated with the design, use and manufacture of devices.
Selects appropriate techniques for problem solving and makes solid and consistent Engineering and Quality recommendations.
Providing expertise in product development systems to project teams Responsibilities: General: Interfaces with R&D, Regulatory Affairs, Clinical, Marketing, Process Development and Manufacturing functions in a project team environment.
Liaise with corporate and divisional quality systems and regulatory affairs personnel in ensuring compliance of product development activities to internal and external requirements.
Monitor the release and updates of quality policies to ensure compliance with Product Development needs and communication of this information to the Product Development Group.
Continually seeks to drive improvements in product and process quality.
Implement, maintain and update procedures that ensure that R&D documentation constantly meets Product Development Process and Design Control requirements.
Provides the quality/independent review at defined design reviews, project design plans, risk management, design verification/validation protocols and reports, for new development projects as well as design/process changes to existing product lines.
Support internal and external audits.
Technical: Provides regulatory compliance, risk management, design control and quality systems expertise to the team.
Summarises, analyses, draws conclusions and makes appropriate decisions from test results or other process related findings.
Fully conversant with verification/validation techniques, risk management, statistical techniques and associated regulatory requirements Build Quality into all aspects of work by maintaining compliance to all quality requirements.
Keeps up to date on all ISO/EN/FDA/MDD and other Product Development related regulatory requirements and relay this information to the Product Development group.
Is a good team member, committed to the projects success and fully motivated to achieve and demonstrate best practices in line with the department and site objectives.
Cardiac Valve Knowledge/Understanding: Knowledge / understanding of EN ISO 5840-1 & -3 Material knowledge of nitinol Material knowledge of animal origin (bovine or porcine) Valve testing Familiar with Product Functional Testing including ageing studies Knowledge of the NCEP process Requirements: Level 8 Bachelors Degree (240 credits) in STEM (Quality, Science or relevant discipline) 3+ years experience in a similar role.
For more information and a confidential discussion on the role, please contactMichelle Mc Inerney.
Skills: Design Assurance Engineer