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Quality Auditing / Systems
Ref No.: 18-05301
Location: Franklin Lakes, New Jersey
Work Authorization:US Citizen
The Quality Auditor is responsible for performance of audits in support of the Client 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 corporate Quality Internal Audits to assure compliance with domestic and international medical device standards and regulations, local procedures, and corporate policies/procedures.

Follow up with the auditee as required to compile information relating to the audits.

Evaluate the adequacy of the provided evidence against the approved Audit Action Plan (AAP). In conjunction with management, develop plans to address inadequate AAP documentation when required

Maintain the audit system software database to record the status of all audits and associated actions.

Provide periodic reports to management based on the audit statuses and defined metrics.

Maintains a high degree of personal professional development through a combination internal and external training and participation in professional associations as appropriate.
Must haves:
• Auditor Certification or Equivalent
• Experience Performing Audits is ? 2 years
o Many resumes indicate they supported audits as the auditee but have not actually been the auditor
• ?3 years in the Medical Device or Pharma Industry
• Knowledge and ability to apply ISO 13485, 21CFR820, etc.
• Written Communication Skills
1st Shift