Associate Director, Quality Systems & Compliance (Design Controls)

The Associate Director Quality Systems & Compliance within Device Quality & Regulatory will support our company's Manufacturing Division QMS Topic 3.3 – MDCP Design Controls and lead continuous improvement initiatives that support every aspect of our business processes, systems, and data.

Requirements

• B.S. and/or M.S. degree in an appropriate Science or Engineering discipline
• Minimum of ten (10) years of experience with in-depth knowledge of pharmaceutical, medical devices and/or medical devices and combination products
• 3 years relevant experience including Regulatory CMC, Quality, development, manufacturing, testing or licensure of pharmaceutical, medical device and combination products; or related fields
• Knowledge of IEC 62304: Medical Device Software Life-Cycle Processes
• Strong knowledge of regulations listed above and ability to work in a team environment identifying gaps in the QMS documents
• Working knowledge for the design, manufacture, packaging, purchasing, testing, release, storage, and distribution of medical devices and/or medical device combination products
• Experience authoring, reviewing, and approving Quality Management System documents
• Solid organizational skills including attention to detail and multi-tasking skills
• Effective people skills and ability to work collaboratively across diverse teams and networks, able to foster cooperation in others
• Effective written and oral communicator, ability to speak up and contribute in a team forum

Benefits

• Medical, dental, vision healthcare and other insurance benefits (for employee and family)
• Retirement benefits, including 401(k)
• Paid holidays, vacation, and compassionate and sick days