Position Overview

The Director, Post Market Quality will provide strategic and tactical direction regarding the post market quality function. This includes reactive surveillance generated from products used in the field (complaints), as well as proactive surveillance generated from marketing, clinical and operational information pertaining to aspects of use of MicroVention products, information generated from scientific literature and publications and information obtained from manufacturing and quality system activities; such as NCR’s, CAPA and risk management activities. Job duties:
  • Overall responsibility for directing the Post Market Quality organization including complaint handling, adverse event reporting and post market surveillance activities.
  • Leading the monitoring of the customer feedback and safety profile of products, including signal detection, and management of signal evaluation activities and documentation.
  • Managing the preparation of aggregate customer feedback reports, and consequent review of Risk Management Plans, Vigilance reports and competent authority responses.
  • 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 of issues based on customer feedback and results of post-market studies.
  • Supporting business development activities, regulatory authority inspections, training, product recalls, and projects, as needed.
  • Leading development and implementation of metrics, periodic reports, and data processing strategies related to customer complaints and contacts to include all available data to identify potential risks with products, or opportunities for improvement within processes.
  • Responsible to engage all appropriate functional groups when a plan is necessary to address an identified high-risk situation.
  • Establishing and maintaining strong relationships to enforce customer feedback investigations and to ensure that adequate corrective actions are being implemented in a timely manner, escalating as appropriate to senior management.
  • Leading interactions with other functions as required with respect to customer feedback investigation, assessing appropriateness of investigations and corrective actions as applicable.
  • Collaborating with key cross functional leadership to develop strategic and tactical objectives to establish an integrated post market surveillance program.
  • Utilizing various inputs from across the quality, clinical, marketing and operations functions, reports to executive management on key performance indicators for products and possible trends in product quality, performance and provides inputs for improvements.
  • Managing department budget and day-to-day functions. Develops budgets, schedules and performance standards. Exercises effective and efficient supervision in terms of resource management.
  • Interacting frequently with internal departments and external customers/vendors; particularly in problem resolution.
  • Hiring, coaching, and counseling associates, including performance reviews, disciplinary action and terminations.
  • Providing technical guidance.
  • Executing other projects as assigned.

    1. Bachelor’s Degree in an Engineering, Science or related discipline.
    2. Minimum of twelve (12) years of experience with Post-Market Surveillance / Customer Complaints concepts, principles and systems.
    3. Minimum of twelve (12) years of experience in the medical device industry, preferably with PMA devices.
    4. Knowledge of FDA Quality System Regulations (21 CFR Part 820) and ISO13485.
    5. At least five (5) years of people management responsibility.
    6. Proven track record in “key leadership” capacity with decision making level of responsibility and authority.
    7. Working knowledge of product risk management for both pre-market development activities and post market safety surveillance activities.
    8. Ability to lead and manage at all levels of the organization.
    9. Strong communication and interpersonal skills
    Desired Qualifications
    1. Advanced degree in Life Sciences.
    2. Knowledge of statistical methods and their application in various aspects of product realization.
    3. Proficiency with Microsoft Office applications.