Microbiology Manager - Medical Device

Elkton, United States

This position is responsible for directing the Microbiology/Chemistry Laboratory and Sterilization programs, serving as technical advisor to corporation’s Quality Management, Regulatory Management, and site management.

Responsibilities:

  • In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
  • Responsible for the implementation of domestic and global regulations in the applicable area of Laboratory and Sterilization issues.
  • Develop and direct the Company’s corporate sterility assurance program and contamination control program which includes; (a.) Radiation Sterilization Validation for Establishing & Maintaining Minimum Dose Requirements and provide guidance in the area of Dosimetic Aspects; (b) Ethylene Oxide sterilization cycle development and validation, annual re-qualification, bio-burden control process, etc.; (c) Provide guidance in the Material Safety evaluation program concerning material Biocompatibility issues; (d) Contamination control - environmental monitoring and control, ( e ) knowledge and management of additional sterilization methods as applicable,  Associate education, etc.
  • Serve as technical advisor in the areas of product sterility, material safety, Endotoxin/pyrogens product contamination, bioburden, sterilization validation, and other microbiological technical related issues.
  • Establish and maintain technical supplier relationships with contract test laboratories, contract sterilizers, Biological Indicator suppliers, laboratory suppliers, and others.
  • Continually examine the scope of testing services being performed to ensure that the needs of the corporation are met and that testing services comply with regulatory guidelines.
  • Oversee regulatory and compliance issues relating to sterilization issues.
  • Develop test methodologies and equipment/instrumentation validation protocols.
  • May participate in supplier and internal audits.
  • Manage the formulation and implementation of strategic business and quality plans for the Test Management Laboratory and Sterilization Programs.
  • Utilizes the systems and processes in place to attract, develop, engage, train, and retain talented Associates; creating a work environment where Associates can realize their full potential, thus allowing the organization to meet business needs.
  • Perform other duties as assigned.

Qualifications:

  • Requires a four-year college degree in Microbiology or Chemistry 
  • Minimum of eight years of experience in Industrial Microbiology, Industrial Sterilization Technology, Cleanroom Management, or Laboratory Management in medical device or pharmaceutical industry, of which a minimum of five years must be supervisory experience. 
  • In addition, experience with radiation sterilization, Industrial Ethylene Oxide sterilization, Moist Steam sterilization, sterilization Biological Indicators, radiation dosimetry, cleanroom/ controlled environment control and material biocompatibility testing preferred. 
  • Intermediate computer software skills, i.e., Microsoft Office.

Microbiology Manager - Medical Device

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Microbiology Manager - Medical Device

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