Job Summary

Job Description

Responsibilities:

• Review sterilization records and all related documentation for completeness, accuracy, and to ensure they meet validated parameters prior to releasing product for distribution.

• Verification and transmittal of various biological and product samples for customers' routine sterilization and validation loads.

• Prepare protocols for customer sterilization validations.

• Work with customers on the development and maintenance of sterilization parameters specific to their products.

• Review test results, run records, analyze temperature and humidity data to ensure they meet the acceptance criteria of the protocol and prepare applicable final reports for customer approval.

• Coordinate and assist in validation product load setup including placement of samples and sensors within product cases and distributed throughout a load. Configure samples and product cases onto pallets according to validation study instructions and retrieve samples at designated times after processing for transmittal to laboratory.

• Configure, set-up, and download sensors used for various customer validation and equipment qualification studies.

• Review and ensure sensors meet calibration specifications prior to and after studies as defined in NPS procedures or customer protocols.

• Interact with individuals from different disciplines (Production, Maintenance, and Customers) to plan, execute and complete simultaneous EO validation activities according to time sensitive schedules.

• Review various facility processing and maintenance documentation including process logs, equipment maintenance, equipment qualifications, and calibration records for completeness and acceptability.

• Maintain sterilization related document historical files by physically sorting/boxing and electronically scanning to ensure access throughout defined retention period.

• Assist with activities related to deviations, CAPAs, customer complaints, and process improvements.

• Assists in document retrieval and gathering for internal and external audits including customers and regulatory bodies.

• Maintain inventory and review usage logs for customer supplied biological indicators used for routine sterilization process monitoring and communicate with customers on needs.

Qualifications:

• Bachelor's Degree with a scientific or engineering background.

• Intermediate level skill in Microsoft Excel (for example: using SUM function, setting borders, setting column width, inserting charts, using text wrap, sorting, setting headers and footers and/or print scaling).

• Intermediate level skill in Microsoft Word (for example: inserting headers, page breaks, page numbers and tables and/or adjusting table columns).

• Ability to lift up to 50lbs and be capable of periodic SCBA use.

• Ability to work safely in environments where hazardous chemicals may be encountered.

• Position requires up to 15% travel

Preferred Qualifications:

• At least 1 year of experience in Quality Systems or in FDA regulated industry.

Benefits - Medline is committed to offering competitive benefits and a variety of choices to best meet the needs of you and your family. For employees scheduled to work at least 30 hours per week, this includes health and well-being, financial fitness, career development, paid time off and more. Employees scheduled to work less than 30 hours per week can participate in the 401(k) plan, access the Employee Assistance Program (EAP), Employee Resource Groups (ERG) and Medline Service Corps. For a more comprehensive list of our benefits, please click here.

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.