- Oversee and supervise the company's quality engineering departments
- Manage device quality assurance activities in compliance with FDA 21 CFR 820, ISO 13485, and other relevant regulatory standards
- Lead corrective action and quality enhancement initiatives
- Engage in technical dialogues with suppliers to identify and implement enhancements in products and processes
- Utilize engineering expertise to conduct complaint assessments and CAPA investigations for better understanding of potential device malfunctions
- Handle budgets effectively
- Extensive experience in Quality Assurance in the medical device industry
- Educational background in Engineering or a related technical field
- Thorough knowledge of FDA regulations, Quality Systems Regulation, and EN ISO 13485:2016 is a must
- Demonstrated experience in team management within the Quality Management System
- Proficient in managing audits conducted by regulatory authorities
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Quality Director - Boston, United States - Connect Life Science
Description
Position: Contract Quality Director
Location: Boston – Hybrid
Duration: 12 Months Contract
Our client is in the process of introducing a class III device to the market and is in need of a Quality Director who possesses critical thinking, data-driven decision-making skills, and a strong focus on quality.
You will be responsible for ensuring adherence to ISO13485 and FDA Quality Systems Regulations. Your primary role will involve serving as the key liaison for FDA and other regulatory bodies regarding all aspects of the company's Quality Management Systems.
Job Responsibilities:
Experience:
Interviews are scheduled for the week commencing 29th April; early applications are encouraged to secure a discussion about this role.