- Initiate medical device quality assurance activities in accordance with (FDA 21 CFR 820, ISO 13485; and other applicable regulatory requirements).
- Support device complaint investigation and failure analysis.
- Participate in design and drawing reviews to ensure that components meet requirements for design and patient safety requirements.
- Interface and take the lead QA role in interactions with suppliers, contractors, and consultants supplying components, subassemblies, and contract processing.
- Lead complaint investigations on returned product.
- Manage corrective action and quality improvement activities.
- Lead in technical discussions with suppliers to identify and implement improvements in products and processes.
- Bachelor's Degree in Engineering or technical field with minimum 5-7 years
- Experience supporting, coordinating and / or leading projects
- Experience in development of new or existing medical devices
- Knowledge of regulatory Medical Device regulations (FDA 21 CFR 820, ISO 13485; and other applicable regulatory requirements).
- Investigation and root cause analysis skills
- knowledge of change control process and project management
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Quality Engineer - Boston, United States - Connect Life Science
Description
Position: Quality Engineer
Location: Boston Hybrid (25% onsite)
Duration: 6 Months Contract
A medical device contract manufacturer, bringing a device to the market are seeking a Quality Engineer who is a critical thinker, data driven, and quality minded.
Job Responsibilities:
Experience: