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DATE ADDED: Thu 11/10/2018

Quality Internal Auditor

New Providence, USA
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COMPANY: GREY STAFFING, LLC

Job Description

 Join a passionate team!

The Quality Auditor is responsible for performance of audits in support of the Quality Internal Audit program.   In this role, he/she is responsible for carrying out audits under the direction of the Senior Manager and/or Director Corporate Internal Audit. In addition, he/she will work with the sites to ensure submitted objective evidence is compliant with domestic and international regulations, corporate standards, and local procedures. He/she will maintain the audit database to monitor audit program metrics and prepare reports for management.

Essential Job Functions

The Quality Auditor is responsible for performance of audits in support of the Quality Internal Audit program.   In this role, he/she is responsible for carrying out audits under the direction of the Senior Manager and/or Director Corporate Internal Audit. In addition, he/she will work with the sites to ensure submitted objective evidence is compliant with domestic and international regulations, corporate standards, and local procedures. He/she will maintain the audit database to monitor audit program metrics and prepare reports for management.


Basic Qualifications

  • Bachelor’s degree in Engineering, Chemistry, Biology, or other related discipline
  • Ability to travel at least 25% of the time 
  • A minimum of 3+ years work experience in the Quality organization of a Medical Device and/or Pharmaceutical company
  • A minimum of 2+ years experience in with auditing compliance with domestic and international regulations for medical devices or pharmaceuticals.
  • Knowledge and experience in CAPA; Root Cause Investigation; Validation (Process, Test Method, Software, and Design); Environmental Monitoring; Sterilization (EtO, Irradiation)
  • Knowledge and ability to apply international regulations and standards of FDA QSR, ISO 13485, EU MDR, and ISO 14971 standards
  • Excellent verbal and written communication skills
  • Demonstrated ability to effectively collaborate and partner with all levels of management while maintaining an appropriate assertive style is critical.
  • Strong analytical skills
  • Effective project management and organizational skills are essential.
  • One of the below certifications or equivalent:

    • Certified Quality Auditor/ISO Lead Auditor Certified
    • Certified Quality Engineer
    • Certified Quality Manager

This is an equal employment opportunities (EEO) to all employees and applicants without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic information, disability, or veteran status.

*PLEASE CHECK YOUR EMAIL / A RESPONSE TO YOUR APPLICATION WILL TYPICALLY ARRIVE VIA EMAIL WITHIN 24 HOURS

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Company Description
As staffing professionals, we have experience placing healthcare candidates in many different settings. We also have been successful in industries such as, pharmaceutical, engineering, IT, therapy, executives, human resources. Contact us today to learn more!


Role: Quality Internal Auditor
Job Type:
Location: New Providence,

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