Director, Quality Laboratories

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.