This is an excellent opportunity to join an award winning world-class Employer in the Life Science industry. Our client is seeking outstanding people who are excited by a start-up environment, recognize the opportunities that this offers and want to be challenged.
In this role you will provide Quality Assurance guidance and ensure compliance in the support of combination device development life cycles from design control through to regulatory submissions and sustainability.
Essential Duties and Responsibilities
• Review and support development of Design Control records, etc. for compliance to internal procedures and regulations (ISO13485, 21CFR Part 820) for the development of combination products.
• Ensure proper justification of statistical analysis and hypothesis testing.
• Review technical reports as well as documents for Design History Files.
• Participate in device risk management activities in accordance with ISO14971
• Evaluation and contribution of regulatory information to applicable documents.
• Aid in establishing proper control plans in development and transfer to manufacturing processes
• Liaise with cross functional departments to implement complaint handling program
• Support scientific, complaint, and test failure investigations
• Support external and internal manufacturing to evaluate and approve change notifications
• Perform statistical and data trend analysis, where applicable.
• Other responsibilities may be assigned in due course in order to support the overall success of the department.
Up to 20% travel.
Education and Experience:
• Requires Relevant degree in Engineering with 5+ years of related experience. May substitute relevant experience for education.
• 2+ year experience in the combination device or medical device industry.
• Experience with post market complaint handling and post Design Transfer DHF maintenance.
If you would like further Information you can contact the recruiter directly:
Kevin Silke | Tel: +353 (0) 1 507 9255