Medical Device Quality Auditor

Winston Salem, NC 27105

Posted: 04/24/2019 Employment Type: DirectHire Industry: Manufacturing,Production Job Number: 93722
We' re seeking a Quality Auditor to join our client, a family-owned medical device company, located in Winston-Salem! This is a permanent, Direct Hire opportunity with an excellent salary. The full-time working schedule will standard day shift (8: 00am-5: 00pm with flexible start time), Monday-Friday. The Quality Auditor assists with all aspects of the Internal Quality Systems Audit Program including audit planning, execution, follow-up and re-audit if necessary. The ideal candidate will be eager to hit the ground running, and will have experience in the medical device or pharma industry, and experience with FDA 820 reports, ISO 13485 and worldwide regulatory auditing. If you are pursuing new career opportunities and feel your skill set would align with the responsibilities of this position, apply today!

- Fully understand the requirements of the Quality System
- Ensure that quality policies and procedures are being followed by various departments
- Provide internal communication regarding compliance issues and applicable regulation changes
- Aid in creation of gap analysis to any new/changed regulations
- Communicate to management issues that require corrective actions
- Maintain files generated from each audit
- Responsible for on-site and off-site audit of quality systems
- Plan audit, execute and prepare audit report

- Experience with FDA 820 reporting and ISO 13485
- Bachelor' s degree in a related field, or experience of such kind and amount as to provide a comparable background
- Work and interact effectively and professionally with and for others throughout various levels of the global organization
- Strictly adhere to safety requirements
- Excellent problem solving skills and ability to work in collaborative and independent work situations and environments with minimal supervision
- Ability to remain calm and receptive in fast paced situations
- Ability to travel between various buildings on the company campus

Submit your resume online, or send directly to ckelly-corne@theresource.Com, to be considered for this position. For additional information, please call our office at 336.970.5208.
While we appreciate all inquiries, only qualified candidates will be contacted for further information.
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