Design Assurance Specialist
Our client is a leading Medical Device company that develops innovative non-surgical interventions for chronic inflammatory Sino-Nasal diseases. They are seeking an experienced Design Assurance Specialist to play a pivotal role in the lifecycle management of their commercially released medical device products.
About the Role
This is an exciting opportunity for a highly motivated and organized individual to join our team as a Design Assurance Specialist. The successful candidate will be responsible for managing design changes, ensuring continued compliance with risk management and design control requirements, and supporting complaint investigations to uphold the safety and effectiveness of our devices.
Responsibilities
* Sustain commercial projects from a Design Assurance perspective
* Lead and execute product/material design changes for commercially released products in accordance with regulatory and internal quality system requirements
* Provide DA technical direction/input to process changes for commercially released products in conjunction with R&D and Manufacturing Engineering
* Maintain and update the risk management file for post-market products
* Generate Design Verification plans, protocols & reports and execute DV testing to support product/material design changes and collection of shelf-life data to support regulatory submissions
* Ensure continued design control compliance (per FDA 21 CFR 820.30 and ISO 13485), including design history file (DHF) maintenance, verification/validation planning, and traceability
* Support complaint handling by participating in technical investigations, root cause analysis, and determining appropriate corrective and preventive actions (CAPA)
Requirements
* 2-3 years experience (can be from MNC or start-up)
* Bachelor's degree (Level 8 NFQ)
* Strong working knowledge of FDA QSR (21 CFR 820), ISO 13485, ISO 14971, and relevant guidance documents
* Experience with design control and risk management throughout the product lifecycle
* Experience with post-market surveillance, complaint investigations, and CAPA systems
Benefits
We offer a comprehensive package of benefits, including:
* Excellent salary
* Pension
* Healthcare
* Yearly bonus
* Share options
If you are interested in discussing further, please let us know and we can arrange a call.