Job Summary

A global biopharmaceutical company is filling a position for a Telecommute Medical Device Quality System and Assurance Director.

Candidates will be responsible for the following:

• Participating in and/or lead various initiatives in support of the Company Manufacturing Division’s Quality Management System (QMS) objectives
• Collaborating and interacting with cross-functional teams to identify opportunities for improvement and drive results while balancing effective operations with transformative initiatives
• Auditing of data, information, procedures and systems to ensure compliance with MDCP current Good Manufacturing Practices (cGMPs), other Worldwide Regulations and Company's requirements. Accountable for other Quality Programs, as assigned. Demonstrated experience implementing Device (pure medical device and/or combination product) Quality systems.

Applicants must meet the following qualifications:

• Ability to travel: 25% of time
• B.S. and/or M.S. Degree in an appropriate Science or Engineering discipline
• Minimum of fifteen (15) years of experience with in-depth knowledge of pharmaceutical, medical devices and/or medical devices and combination products
• Proven ability to be accountable for other Quality Programs
• Demonstrated experience implementing Device (pure medical device and/or combination product) Quality systems