- plan, direct and control the company's quality system
- with the project management team
- medical device quality assurance activities in accordance with (FDA 21 CFR 820, ISO 13485; and other applicable regulatory requirements).
- device complaint investigation and failure analysis.
- corrective action and quality improvement activities.
- Lead in technical discussions with suppliers to identify and implement improvements in products and processes.
- Degree in Engineering or technical field
- in Medical Device
- in leading projects
- in development of new or existing medical devices
- of regulatory Medical Device regulations (FDA 21 CFR 820, ISO 13485; and other applicable regulatory requirements).
- of change control process and project management
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Quality Assurance Manager - Boston, United States - Connect Life Science
Description
Position: Contract Quality Manager
Location: Boston – Hybrid
Duration: 12 Months Contract
A medical device manufacturer, bringing a device to the market are seeking a Quality Manager who is a critical thinker, data driven, and quality minded.
Job Responsibilities:
Experience:
Interviews taking place week commencing 15th April, please apply early to discuss this position.