Director, Post Market Surveillance Quality
Our client needs a Director of Post Market Surveillance Quality who sees the world differently. We’re looking for professionals with minimum of twelve years’ experience who don’t see obstacles but opportunity when it comes to medical device development. The Director of Post Market Surveillance Quality position is full-time, and is located in Tustin California. We’re looking for problem solvers, innovators and those inspired by the work we do in making a difference today and with future generations.
• Overall for directing the Post Market Surveillance.
• Lead the monitoring of the customer feedback and safety profile of products.
• Managing high risk customer feedback escalation process.
• Providing scientific and regulatory input into evaluation of customer feedback.
• Supporting operational and process improvement activities, to improve early signal detection and management based on customer feedback and results of post-marketing studies.
• Supporting business development activities, regulatory authority inspections, training, product recalls, and projects, as needed.
• Managing the preparation of aggregate customer feedback reports, and consequent review of Risk Management Plans, relevant sections of regulatory documents and health authority responses.
• Managing department budget and day-to-day functions. Develops budgets, schedules and performance standards. Exercises supervision in terms of costs, methods, and staffing.
• Interacting frequently with internal departments and external customers/vendors; particularly in problem resolution.
• Hiring, coaching, and counseling employees, including performance reviews, disciplinary action and terminations.
• Providing technical guidance.
• Assisting with various projects as assigned.
• Minimum of twelve (12) years of experience in the medical device industry, preferably with PMA devices.
• Knowledge of FDA Quality System Regulations (21 CFR Part 820) and ISO13485.
• At least five (5) years of people management responsibility.
• Working knowledge of product risk management for both pre-market development activities and post market safety surveillance activities.
• Ability to lead and manage at all levels of the organization.
• Strong communication and interpersonal skills.
• Knowledge of statistical methods and their application in various aspects of product realization.
• Proficiency with Microsoft Office applications.
• Bachelor’s Degree in an Engineering, Science or related discipline.
• Advanced degree in Life Sciences.