Seeking a hands-on Director of QA/RA to own the Quality Management System and Regulatory strategy for a Class II HW/SW medical device company. This is an ideal role for a Manager/Senior Manager who is looking for their next step up to Director level. 

Key Responsibilities

• Quality Management: Full ownership of QMS maintenance and Post-Market via QT9 (eQMS/ERP).

• Design Quality: Direct Design Controls, Risk Management, and NPD for electromechanical systems.

• Regulatory: Lead US 510(k) strategy; partner with external consultants and author/review technical documentation.

• Supplier Quality: Manage ~50 suppliers; oversee the transition of new products to a contract manufacturing model over the next 18 months.

• Team Leadership: Direct management of two reports initially 

Requirements

• 6–12 years in MedTech QA/RA.

• Direct experience with Class II Electromechanical (HW/SW) products.

• Strong working knowledge of Design Controls and 510(k) submissions (submission authorship not required)

• Prior experience in supplier management and QMS maintenance.