Internal Auditor for Quality Systems (Medical Device Pharmaceutical) - OQSIE

nternal Auditor for Quality Systems (Medical Device Pharmaceutical)
The Internal Auditor will lead Quality Management System audits for compliance with 21 CFR 820, 21 CFR 210, and 21 CFR 211; ISO 13485, and company policies to identify weaknesses in documentation, process or operational compliance at the company. The Internal Auditor will be responsible to perform all aspects of the Internal Audit program including: creation of an audit schedule, prepare audit agenda, lead internal audits with minimal direction, write audit reports, and review proposed corrective / preventive actions to audit findings. Audit findings will be communicated to the site Quality Compliance Lead.
 
Qualifications:

1. Bachelor's degree in a technical field (Biology, Chemistry, Engineering or equivalent discipline.
2. Minimum of 7 years' experience in medical device or pharmaceutical production environment. With minimum of 2 years' experience in auditing role for pharmaceutical/medical device GMP regulated industries.
3. Applied knowledge in quality systems and strong knowledge of regulatory requirements including 21 CFR 820.
4. Mental Abilities – Ability to define problems, collects data, establish facts, and draw valid conclusions.
5. Proficient in Microsoft Office (Word, Excel, Access, PowerPoint) To perform this job successfully, an individual should have knowledge of Microsoft Visio, Adobe Professional, Quality Management System.
6. Interpersonal – Interfaces with management and non-management employees across all departments within the company as well as with Regulatory Agencies.
7. Excellent verbal and written communication skills.
8. ASQ Certified Quality Auditor (or other 3rd party auditor certification) preferred but not required.
9. Ability to be flexible, resilient, and adaptable to changing priorities in a fast paced, high pressure environment.
10. Exercise sound judgment and ability to work effectively with a diverse workforce.