Senior Quality Engineer

1 month ago


Manassas, United States Aurora Life Sciences Inc Full time

The Company

Our client is a leading medical device manufacturer with a strong reputation for being best in class. You will be joining an innovative team that have created a life changing product in the market. If you are a passionate, driven and dedicated Quality Engineer who has a passion for bringing safe medical devices to market this would be a great opportunity to join a dynamic team working with a cutting edge product.

The Role

Partner with Manufacturing Engineers to develop and qualify manufacturing processes.

Review and approve design changes.

Support or lead root cause analysis investigations for production-related or quality-related non conformities and develop and aid in the implementation corrective actions

Support elements of the Quality System such as, NCRs, CAPAs and Complaints.

Audit the manufacturing line to ensure compliance to governing procedures is being met

Key Skills

Experience with nonconformances, investigations, root cause analysis, risk analysis and corrective/preventive actions.

Must be familiar with 21CFR820, ISO 13485, and ISO14971 requirements

Must have strong project management and documentation skills.

Must take initiative and have the ability to conduct hands-on work.

Benefits

28 days Holiday + Bank Holiday

Health Care

35hr Per Week

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