Quality Auditor Coordinator Jobs

PTS Advance is looking to speak with Quality Auditor professionals to join our client which is an international Medical Device organization that has multiple product lines ranging from Class 1 to Class 3 medical devices. This is a contract opportunity that is fully onsite in Nashville, TN.
Main Responsibilities

• Draft audit reports for lead auditors and audit teams
• Responsible for storing the current audit schedule in PIL tool at regular intervals
• Track and enter quality audit outputs (Internal and External) into PIL tool to ensure proper storage of the audit schedule, audit agenda, audit report, document list, etc.
• Manage External Audit data to ensure external audit reports and findings are recorded in PIL
• Completes work with a limited supervision
• Generates departmental metrics and reports to management
• Generates queries in the CAPA PIL tools or other identified tools in preparation for audits
• Responsible for generating audit engagement in PIL tool prior to each audit
• Draft audit reports for lead auditors and audit teams

Required Qualifications

• 1-3 years of experience in the medical device industry required
• Proficient technical writing skills
• Bachelor's degree, or equivalent experience
• Advanced experience with data entry
• Basic understanding of CAPA, as well as global medical device regulations, requirements, and standards such as 21 CFR Parts 803, 806, and 820, ISO13485, and EU MDR
• 1-3 years working in quality management systems and/or regulatory affairs
• Basic experience with data analysis and research
• 1-3 years of experience in a regulated industry

Not open for C2C.
If you or someone you know may be interested, please send your resume to [email protected] or visit us at jobs.PTSadvance.com to learn more about the role. #LifeSciences #PTSAdvancejobs #PTSAdvance
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