Director of Quality Assurance Leadership

4 weeks ago

South San Francisco, California, United States Jobot Full time
Job Summary

We are seeking a highly experienced and dynamic leader to fill the role of Director of Quality Assurance. This is an excellent opportunity for an individual with a solid background in Quality Assurance, Compliance, and Manufacturing to lead and direct a team of professionals in ensuring the highest level of quality in our products.

Key Responsibilities
  • Serves as Management Representative
  • Hosts FDA and regulatory agencies' quality system audits
  • Sets up Quality System policies and procedures to ensure compliance with FDA QSR, ISO 13485, and EU MDD requirements
  • Routinely evaluates the existing quality system to identify opportunities to streamline processes, and to ensure compliance with FDA QSR, ISO 13485, and MDD
  • Writes quality objectives
  • Manages quality resources, including personnel, equipment and budget in alignment with departmental and corporate goals
  • Performs Management Reviews and advise management of any product or process related issues and makes recommendations for improvements.
  • Plans and manages internal audit activities and coordinates audit corrective actions
  • Manages the quality group to ensure effective development and implementation of the Quality System Processes
  • Performs other duties as assigned
Requirements
  • Bachelor's degree in Engineering, Quality Assurance, or related field. A Master's degree will be an added advantage.
  • Minimum of 10 years of experience in a Quality Assurance role in the manufacturing industry, preferably in the medical device sector.
  • Minimum of 5 years of supervisory experience. Excellent leadership and team management skills.
  • Proven experience with QSR, ISO 13485, EU MDD, and other international quality standards.
  • Extensive knowledge and experience with medical device and equipment manufacturing, a plus for experience with catheters, sterilization, and packaging processes.
  • Experience in preparing and submitting Premarket Approval (PMA) applications for Class III medical devices.
  • Strong knowledge of risk assessment and PFMEA processes.

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