The ideal candidate is a critical thinker who will proactively improve the quality systems of the company through internal audits, participation in process improvement programs, and interaction with key partners to obtain constructive feedback.
Responsibilities
Review and approve applicable document change orders.
Assist management in developing strategic regulatory approaches for new product/business development.
Oversee the day-to-day activities related to the quality and safety of the Company's medical device manufacturing.
Establish and assist with the implementation of quality systems and system improvements.
Qualifications
BA or BS in the life sciences or a related degree program
5+ years in a role with extensive quality experience in an FDA-regulated environment, with knowledge of commercial-stage medical devices and/or drug-device combination products.
Experience successfully interfacing with accreditation and regulatory agencies (ISO,FDA), writing responses and other documents required in a regulated environment.
Applications without resumes attached will not be considered.
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