Technical Assurance Specialist
1 week ago
This highly motivated and experienced individual will play a key role in supporting the lifecycle of commercially released medical device products.
Main Responsibilities:- Support sustaining commercial projects from a Design Assurance perspective, ensuring continued compliance with global standards.
- 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, ensuring all identified risks are adequately documented and mitigated.
- Generation of Design Verification (DV) plans, protocols & reports and execution of DV testing to support product / material design changes.
- Ensure continued design control compliance, 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).
This is a critical role that requires strong working knowledge of FDA QSR (21 CFR 820), ISO 13485, ISO 14971, and relevant guidance documents.
Requirements:- Bachelor's degree (Level 8 NFQ) in a relevant technical discipline (e.g., Engineering, Science).
- Minimum 2-3 years of experience in design assurance, quality engineering, or product development in the medical device industry.
- Strong analytical, communication, and documentation skills.
- Detail-oriented with the ability to manage multiple tasks in a fast-paced environment.
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