Director, Quality Laboratories

Position Overview

Support the development and manufacture of medical devices. Assist in the development, direction, and strategic planning for critical quality areas including Sterilization, Microbiology, Biocompatibility, cleanroom qualifications, and environmental monitoring. Job duties:
  • Supervise, mentor, and provide leadership to staff. Manage resource allocation and provide job performance feedback.
  • Assist in defining department goals and strategy for activities in Sterilization, Microbiology, Biocompatibility, clean room qualifications, and environmental monitoring for all sites.
  • Establish requirements for Sterilization Specialists, sterilization contractors and in-house sterilization equipment.
  • Direct team members and activities regarding the implementation of new sterilization processes and in-house sterilization equipment including associated sterilization validations.
  • Direct departments that lead validations for both in-house and contracted sterilization processes.
  • Develop company requirements for environmental monitoring and ensure these requirements are adequately documented and implemented.
  • Direct team members to maintain the validated status for controlled areas. Ensure staff completes the required testing for environmental monitoring and product bioburden testing.
  • Oversee the Microbiology function of the organization:
    • Direct team members and activities to assess risks and identify possible sources of contamination.
    • Develop and execute testing protocols to validate the sterility and biocompatibility of medical devices.
    • Conduct regular environmental monitoring to detect and control potential sources of contamination. Determine the most effective sterilization methods.
    • Responsible for understanding and complying with relevant regulatory requirements.
  • Oversee the Biocompatibility program:
    • Supervise the Biocompatibility program and manage the team's daily performance, ensuring accountability among team members.
    • Conduct risk assessments to identify potential hazards associated with the medical device's materials, manufacturing processes, and intended use. Develop and implement strategies to mitigate identified risks.
    • Create a comprehensive biocompatibility testing plan based on the risk assessment findings.
    • Ensure that all biocompatibility testing and evaluations adhere to relevant regulatory requirements.
    • Evaluate the data obtained from testing and assess any potential adverse reactions, determining if they fall within acceptable limits.
    • Maintain comprehensive documentation of the entire biocompatibility program, including the testing plan, test reports, risk assessment, and risk management actions.
    • Investigate complaints and adverse events promptly to identify the root cause and implement corrective actions to prevent future occurrences.
    • Conduct periodic reviews of the biocompatibility program to ensure compliance with the latest regulations and standards.
    • Collaborate closely with other company departments, such as R&D, Manufacturing, Quality Assurance, and Regulatory Affairs to foster a holistic approach to biocompatibility throughout the product lifecycle.
  • Comply with applicable Laws and Regulations, adhere to Quality Management System processes and requirements as well as demonstrate Ethics and Integrity in all matters and at all levels throughout the organization.
  • Perform other duties and responsibilities as assigned.

Job Details

Job ID 11645BR

Aliso Viejo, California, USA

Salary Range:

$142,000 - $200,000 (compensation could be higher/lower based on experience, education and skill sets)

    1. Bachelor’s degree in Engineering, Life Sciences, or other relevant discipline, or equivalent combination of education and related experience.
    2. Minimum of twelve (12) years of relevant professional experience in medical device quality laboratories, quality engineering, product development, or product manufacturing.
    3. Minimum of five (5) years of management or leadership responsibility.
    4. Minimum of three (3) years of experience in project management. Ability to lead complex technical projects.
    5. Must have hands-on experience with leading Quality Laboratories and/or similar function at established medical devices and/or pharmaceutical organizations.
    6. Ability to define department goals and to develop strategies to achieve these goals.
    7. Expertise with EtO, beam, gamma, and steam sterilization. Experience in applying sterilization validation and control processes described in ISO 11135, ISO 11137, and ISO 17665. Hands-on experience with different types of Sterilization validations.
    8. Strong understanding and expertise in Physical and Life Sciences.
    9. Strong understanding of analytical test method validations.
    10. Solid understanding of applicable Microbiology principles and practices.
    11. Strong understanding of 10993-1 and its subsets and their application to medical devices.
    12. Experience with clean room requirements, qualifications, and maintenance.
    13. Working knowledge of associated regulatory requirements and industry practices.
    14. Highly proficient at transferring medical device regulatory requirements into practice. Strong ability to translate regulation requirements into practical procedures.
    15. Strong ability to write and review procedures.
    16. Strong ability to work effectively and confidently in a team environment.
    17. Strong skills in medical product quality assurance.
    18. Strong skills in directing Managers and Engineers that coordinate all aspects of testing (test protocol preparation, sample preparation, lab testing, data analysis and test report preparation).
    19. Ability to manage department managers and group leaders who manage technical staff.
    20. Excellent written and verbal communication skills.
    21. Proficient with MS Excel, Word, Project, Outlook, and Teams.
    Desired Qualifications
    1. Advanced degree preferred.
    2. Ability to motivate cross-functional teams to complete their assigned tasks.
    3. Experience and/or strong understanding of process chemistry.