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Sr Mgr Sterility Assurance @Medline Industries, LP

[Hiring] Sr Mgr Sterility Assurance @Medline Industries, LP

Mar 29, 2025 - Medline Industries, LP is hiring a remote Sr Mgr Sterility Assurance. 💸 Salary: $132,600.00 - $199,160.00 annual. 📍Location: USA.

This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more.

Role Description

Oversee sterility assurance personnel in cycle development, maintain compliance for all Medline sterilization requirements, oversee sterility releases, identify and qualify sterilization and laboratory vendors. Responsible for providing technical guidance and being a decision maker for ethylene oxide, steam, radiation and novel sterilization processes strategies.

  • Lead validation sterilization process and optimize the current processes to reduce sterilization costs and increase capacity.
  • Review and approve sterilization protocols and reports.
  • Manage the development, maintenance, and validation of new process challenge devices for ethylene oxide sterilization cycles and conduct training for others.
  • Monitor AAMI/ISO standards and review changes to ensure sterilization validations compliance.
  • Review and revise Corporate Sterilization procedures to make sure they are in line with current practices and regulatory requirements.
  • Direct the internal, customer and regulatory audits and ensure that recommendations and corrective actions are appropriate and efficiently acted upon and documented.
  • Review and approve control system software upgrade and validation for in-house and overseas sterilization facilities.
  • Provide global support for FDA and ISO inspections related to sterilization activities.
  • Provide support for global technical equipment and validation efforts to include microbiological process qualifications, software validation, process performance qualifications and equipment troubleshooting.

Management responsibilities include:

  • Typically manages through multiple Managers and/or Supervisors.
  • Oversee major projects/programs/outcomes; Budget responsibility; interpret and execute policies for departments/projects and developments.
  • Recommend and implement new policies or modifications to existing policies.
  • Provide general guidelines and parameters for staff functioning.
  • Hiring staff, recommending pay increases, performing performance reviews, training and development of staff, estimating personnel needs, assigning work, meeting completion dates, interpreting and ensuring consistent application of organizational policies.

Qualifications

  • Bachelor’s degree with a scientific or engineering background.
  • Member of AAMI sterilization working group.
  • At least 5 years of sterilization experience with ethylene oxide and radiation processes.
  • At least 2 years of experience directly managing people including hiring, developing, motivating, and directing people as they work.
  • Experience in learning and assimilating new information for both current and future problem solving and decision making.
  • Skill and ability to diagnose, isolate, and resolve complex issues and recommend and implement strategies to resolve problems.
  • Demonstrated ability to influence, lead and direct individuals in multiple functional areas.
  • Demonstrated ability of controlling and coordinating concurrent projects, competing priorities and critical deadlines.

Requirements

  • Position requires travel up to 15% of the time for business purposes (domestic and international).
  • Position requires work in environments where hazardous chemicals may be encountered.

Benefits

  • Competitive total rewards package.
  • Continuing education & training.
  • Tremendous potential with a growing worldwide organization.
  • Health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average.
  • For roles where employees work less than 30 hours per week, benefits include 401(k) contributions as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp.

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📍 Be aware of the location restriction for this remote position: USA
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Back to Remote jobs  >   All others
Sr Mgr Sterility Assurance @Medline Industries, LP
All others
Salary 💸 $132,600.00 - $199,160.00 annual
Remote Location
USA
Job Type full-time
Posted Mar 29, 2025
Apply for this position Unlock 54,611 Remote Jobs
📍 Be aware of the location restriction for this remote position: USA
Beware of scams! When applying for jobs, you should NEVER have to pay anything. Learn more.
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