Quality Internal Auditor


Job ID 18-00184

Industry Pharma

Job Type Permanent

Location New Providence, NJ

Description

The Quality Auditor is responsible for performance of audits in support of Corporate 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.



Qualifications

Requirements:
Bachelor's degree in Engineering, Chemistry, Biology, or other related discipline
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
 

Candidate Details:
2+ to 5 years' experience
Seniority Level - Associate
Management Experience Required - No
Minimum Education - Bachelor's Degree
Willingness to Travel – Often
 

Ideal Candidate:
Certified Quality Auditor
Hands-on Experience conducting quality audits internally at manufacturing sites
Excellent communication and interpersonal skills