Key Facts

Remote From:

United States

Category: Auditor

Freelance

Senior (5-10 years)

English

Hard Skills

European Quality Improvement Systems Steam Sterilization Medical Device Directive FDA Regulations Sterilization Validation ISO 13485 Standard Workday Adaptive Planning Microsoft Networking

Other Skills

•
Interpersonal Communications

Roles & Responsibilities

Bachelor's Degree
Minimum of 3 years hands-on sterilization work experience in Ethylene Oxide or Radiation (Gamma, Electron Beam or X-Ray)
Knowledge of the Standards as they relate to Sterilization
Minimum of 5 years auditing experience (not necessarily sterilization)

Requirements:

Conduct sterilization process audits (Ethylene Oxide and/or Radiation) at client sites
Evaluate compliance with sterilization-related standards and quality systems (e.g., ISO 13485 or 21 CFR 820)
Prepare audit reports, summarize findings, and recommend corrective actions
Travel domestically and internationally to perform audits and meet client schedules

Performance Review Institute (PRI)

Non-profit Organization - Charity

About Performance Review Institute (PRI)

The Performance Review Institute (PRI) is headquartered in Pittsburgh, Pennsylvania in the USA, with offices in London, UK to serve Europe and in Beijing, China and Aichi, Japan serving the Asia-Pacific region. PRI was originally set up to administer Nadcap – the industry-managed special process and product accreditation program for the aerospace and defense industries. Nadcap was developed by Government and Industry to continually improve quality while reducing costs. In 1995 we established PRI Registrar, a management systems registrar which provides international third-party certifications to standards such as ISO 9001, AS9100 and ISO 14001, among others. In 2007, responding to customer demand, we established eQuaLearn, a special process and quality training program and eQuaLified, an industry managed special process personnel qualification program. More recently, we have applied the Nadcap model to other industries where safety and quality are shared values, focusing on medical device manufacturing through the MedAccred program, and the transportation and power generation industries through the TPG program.

Company type: SME

Industry: Non-profit Organization - Charity

Founded: 2018

Company size: 51 - 200

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Job description

Overview:

This Sterilization Medical Device Auditor position is an excellent opportunity for recent retirees or consultants that have Sterilization experience in Ethylene Oxide or Radiation(Gamma, Electron Beam &/or X-ray).

Our auditors enjoy traveling domestically and/or internationally, a flexible schedule (some auditors perform 1 or 2 audits a month, while others desire to audit every week), competitive compensation that includes a daily rate plus travel expenses, meeting new people and keeping in touch with technology and the latest developments, networking with other industry professionals.

To learn more about this auditor position, please review these General Guidelines.

Qualifications:

The ideal auditor candidate will possess the following criteria:

Bachelor's Degree
Minimum of 3 years hands-on sterilization work experience in Ethylene Oxide or Radiation (Gamma, Electron Beam &/or X-Ray)
Knowledge of the Standards as they relate to Sterilization
Minimum of 5 years auditing experience (not necessarily sterilization)
Quality Assurance System experience (primarily ISO 13485 or 21CFR820)