Manager Quality Assurance

About the role

This position provides leadership and guidance for the department, has responsibility for recruiting, developing and retaining talented employees, supports company goals and objectives, and communicates key information to staff members and senior management.

Responsibilities

• Develops direct reports by securing appropriate training, assigning progressively challenging tasks, applying progressive disciplinary action as appropriate and conducting formal written and verbal performance reviews.
• Monitors daily work operations and provides direction and guidance to lower-level supervisors, experienced exempt employees, or skilled nonexempt staff to achieve unit or project goals.
• Monitors compliance with company policies and procedures (e.g. compliance with FDA, MedDev, DOH regulations etc).
• Notifies appropriate personnel for possible litigation and aids and responds to requests for information related to litigation concerns.
• Monitors complete complaint handling process from first contact through closure of file and notifies appropriate personnel of issues that prevent a smooth flow.
• Maintains personnel records and where appropriate develops work schedules for departments customer complaint hotline to ensure no customers are transferred to v-mail during business hours.
• Develop strategies for regulatory reporting of medical devices.
• Coordinate MDR, Vig, MHLW, reporting activities for a variety of device regulatory requirements including: US post market studies, IDE exemptions, international regulatory reporting and annual summaries.
• Develop and deliver presentations to global regulatory agencies and other business units. Topics may include MDR position strategies, compliance issues or new initiatives such as Global Harmonization.
• Coordinate Division comments on proposed regulations.
• Represent Division in industry feedback for changes in regulatory law.
• Serve as internal consultant on regulatory issues such as regulatory processes, interpretation of regulatory laws or review of proposed regulatory position changes.
• Participate in department systems development initiatives, which may include complaint database development.

Requirements

• Minimum of a Bachelor's degree or an equivalent combination of education and work experience.
• Minimum of 6 years of experience within the healthcare, medical device, or biotechnology industry.
• Medical Device experience highly preferred.

Pay

The base pay for this position is $99,300.00 – $198,700.00. In specific locations, the pay range may vary from the range posted.