Job Summary

Responsible for performing and assisting the Sterilization group in cycle development, maintaining compliance for all Medline sterilization requirements with focus on domestic validations, overseeing sterility releases, identifying and qualifying sterilization and laboratory vendors. Responsible for technical guidance and training to domestic and overseas group with sterilization processes.

Job Description

Responsibilities:

Manage sterilization assurance specialists to work with divisions to validate sterilization process as requested and find ways to optimize the current processes to reduce sterilization costs and increase capacity.
Maintain compliance with vendor audits and supplier evaluations per SOP requirements. Conduct customer tours and provide technical letters as needed. Review and approve sterilization protocols and reports. Assist various divisions during special evaluation studies including residual testing, product adoption, functionality testing, stability testing, and 510K submissions.
Develop, maintain, and validate new process challenge devices for ethylene oxide sterilization cycles and conduct training for others.
Provide technical guidance and training to domestic and overseas groups.
Stay current with AAMI/ISO standards and review changes to make sure sterilization validations are in compliance with new requirements. Review and revise Corporate Sterilization procedures to make sure they are in line with current practices and regulatory requirements. - Participate during internal, customer and regulatory audits and ensure that recommendations and corrective actions are appropriate as well as efficiently acted upon and documented.

Management responsibilities include:

Typically oversees professional employees/teams OR typically manages non-professional employees through Supervisors in manufacturing, distribution or office environments
Day-to-day operations of a group of employees.
May have limited budgetary responsibility and usually contributes to budgetary impact; - Interpret and execute policies for departments/projects and develops. 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.
Certification / Licensure - Member of AAMI sterilization working group.
At least 4 years of sterilization experience with ethylene oxide and radiation processes.
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.
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.

Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization.

The anticipated salary range for this position:

$115,440.00 - $173,160.00 Annual

The actual salary will vary based on applicant's location, education, experience, skills, and abilities. This role is bonus and/or incentive eligible. Medline will not pay less than the applicable minimum wage or salary threshold.

Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average. For a more comprehensive list of our benefits please click here. 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.

Every day, we're focused on building a more diverse and inclusive company, one that recognizes, values and respects the differences we all bring to the workplace. From doing what's right to delivering business results, together, we're better. Explore our Diversity, Equity and Inclusion page here.

Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.