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Quality Systems Auditor in Naples, FL , at Arthrex
Quality Systems Auditor
Perform Internal Quality System Audits to evaluate and determine conformance to quality system standards pertaining to the development, manufacture, and distribution of medical devices.
Essential Duties and Responsibilities:
- Performing internal audits
- Issuing related corrective actions and following up on effectiveness
- Providing audit reports and trending of related information.
- This role requires travel up to 25% of the time.
The above statements describe the general nature and level of work being performed in this job. They are not intended to be an exhaustive list of all duties, and indeed additional responsibilities may be assigned, as required, by management.
Education and Experience:
A Bachelor’s degree required; preferably in Engineering, Biology, Math, Chemistry or Computer Science. Minimum two years of experience minimum working in a quality systems auditing capacity as a quality systems auditor, preferably with internal or supplier audit experience in a Medical Device Company.
Knowledge and Skill Requirements/Specialized Courses and/or Training:
- Knowledge of statistical processes and trending preferred.
- Certified Auditor preferred.
- Working knowledge of international standard ISO 13485:2016 for medical devices preferred
- Working knowledge of 21 CFR Part 820, F.D.A. Quality System Regulation
- Familiarity with medical device regulations MDR/MDD for European Union, Japanese MHLW, and Canadian CMDR preferred
- Familiarity with 21 CFR Part 11, FDA Electronic Records / Electronic Signatures preferred
Machine, Tools, and/or Equipment Skills:
PC proficient, ability to use different database applications, strong MS office skills, especially Excel and Power Point. Working knowledge of Pilgrim Smart Solve software as well as SAP and Agile is desired.
All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.