Job Description

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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