Job description

Steri-Tek helps to improve and save lives by sterilizing medical devices, pharmaceuticals and tissue products with electron beam radiation. The company is only 6 years old and expanding nationally. We are building our team in Fremont CA as well as opening a new facilities in Dallas TX and Raleigh NC. Our customers range from large medical device companies that send us truckloads of products down to the smallest start-ups that use us to sterilize new products that will eventually save and/or improve lives. Customers frequently comment on the great culture of the company.

https://apply.workable.com/steritek/j/BA556A9AEC/

Requirements

Assist customers in completing the sterilization validation of their products to the required standards. Assist customers in complying with regulations by maintaining open and professional communication. Provide superior customer service. Successful completion of this position includes complete and proper execution of the Steri-Tek Standard Operating Procedure (SOP) Manual.

Manage various project throughout the company. This includes Validations, Dose Mapping, Quality Assurance, Marketing and Operations. Assist customers in complying with regulations by maintaining open and professional communication. Provide superior customer service. Successful completion of this position includes complete and proper execution of the Steri-Tek Standard Operating Procedures (SOP) and Quality Manual.

Responsiblities:

• Receive and coordinate all Dose Map projects
• Complete all Dose Map projects to the required standards and within the customer’s specified timeline.
• Contact customer to confirm validation requirements.
• Create all required documentation including: building project folders, writing protocols and final reports.
• Prepare final documentation for distribution to customer, ensuring documentation meets document control requirements.
• Follow all required Standard Operating Procedures (SOP) in preparation for Dose Mapping.
• Maintain and update as needed SOP, WI & FORM for process efficiency and compliance.
• Technical Customer Support and Documentation
• Answer customer questions regarding Dose Mapping, packaging, product materials and any other question related to dose mapping in a timely and professional manner.
• Be knowledgeable in the areas of dosing, product orientation and material types so as to be a resource to customers, including: ISO 11137, AAMI TIR33, AAMI TIR17, AAMI TIR29 and Steri-Tek Dose Mapping SOP.
• Prepare and distribute final documentation to customers including: price quotes, Dose Map reports and other documentation.
• Prepare Process Documentation for Irradiation
• Ensure all required reporting and documentation is completed accurately and on time.
• Ensure all documentation is completed per the Company SOP’s.
• Obtain all required document reviews and approvals.
• Reporting
• Meet all established deadlines.

Requirements:

• High School Diploma
• Proficient in English language (written and spoken)
• Microsoft Office

Preferred Qualifications:

• Medical Device, Pharmaceutical, Human Tissue and/or Biomedical industry experience – 1-3 years
• Bachelor’s Degree in Life Science or related field 3 years relevant experience
• Excellent customer communication

Benefits

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

Job Type: Full-time

Pay: $30.00 - $32.00 per hour

Benefits:

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

Schedule:

• Monday to Friday

Ability to commute/relocate:

• Fremont, CA 94538: Reliably commute or planning to relocate before starting work (Required)

Experience:

• medical or bio-tech: 1 year (Preferred)

Work Location: One location

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