Job description

Steri-Tek is dedicated to providing a high-quality sterilization service and superior customer service to the industries that it serves.

The Irradiation Specialist will be responsible for providing customer support and executing dose mapping and validation projects. They will be expected to answer technical questions in a timely and professional manner, ensure that customer products are processed per specification, and maintain accurate records. The Irradiation Specialist will also be responsible for executing dose audit and validation projects, writing reports, and ensuring equipment calibration.

Successful completion of this position includes complete and proper execution of the Steri-Tek Standard Operating Procedure (SOP) Manual.

Customer Support

• Answer customer questions regarding validations, dose mapping, packaging, product materials, and any other technical questions in a timely and professional manner.
• Be familiar with ISO 11137 standards (11137-1, 11137-2, 11137-3), and how e-beam irradiation affects different materials.
• Inform customers of optimal packing and box configurations, how density of product affects dosing, and how temperature can impact a product.

Radiation Services Projects

• Maintain a basic level of knowledge of Quality System Requirements (ISO 13485, 21 CFR 820).
• Ensure customer products are prepared and processed per specification following the applicable SOP’s.
• Write protocols for dose studies, perform the dose studies, and write reports for the dose studies.
• Measure dosimeters and be proficient with spectrophotometers.
• Assist with equipment calibration and report writing.
• Assist in dosimeter calibration.
• Assist in extra Radiation Services tasks.
• Ensure incoming products have been received and prepared for applicable processing needs.
• Contact customers as required to resolve any discrepancies with incoming product.
• Ensure documentation and reporting for projects are accurately completed and on time.
• Validations Projects
• Assist with dose audit projects.
• Assist with report validations projects.
• Assist with verification dose projects.
• Goals and additional responsibilities
• Provide technical expertise to other departments on an as-need basis (e.g. provide technical background to Quality for non-conformance, CAPA process. Provide technical background to Radiation Services for validation activities).

Other duties as assigned by Manager.

Qualification Requirements:

• Proficient in English language (written and verbal)
• Microsoft Office
• High School Degree (or equivalent)

Preferred Qualifications:

• Medical Device industry experience – 1-3 years
• Customer Service experience – 1-3 years
• Bachelor’s Degree

Steri-Tek offers medical, dental, vision, 401K with matching, paid holiday, and paid time off.

Work Schedule: Monday through Friday, 8:30am - 5:00pm

Job Type: Full-time

Pay: $22.00 - $25.00 per hour

Benefits:

• 401(k) matching
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday

Ability to commute/relocate:

• Lewisville, TX 75067: Reliably commute or planning to relocate before starting work (Required)

Application Question(s):

• Do you have experience in a regulated industry, working with OSHA, FDA or ISO standards?

Work Location: In person

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