Insight Global is seeking a QMS Auditor to join the business assurance group for one of our Inspection and Certification clients. This position will be responsible for conducting audits related to the production of medical devices for ophthalmology. The day to day includes meeting with senior decision makers at client sites, collecting and analyzing information, and assisting with certification procedures for various medical device standards (ISO 13485, MDSAP, MDD and MDR). This person will be travelling a minimum of 80% of the time both domestically and internationally (weekend travel as needed).
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3+ years of experience working for a Certification Body (CB) / Notified Body (NB) / Auditing Organization (AO)
MDD and MDR auditor certification within the past 3 years
ISO 13485 and MDSAP auditor certification (no time constraint)
Experience with the following non active medical devices: MDN1206, MDN1101 (also classified as MD0105, MD0201 and MD0203)
Bachelors degree in Engineering, Bioscience, Biomedical, Science, or a related discipline
Comfortable with 80% travel requirements
Experience with ophthalmology or animal/soft tissue products
2+ years of sterilization technology experience (typically moist heat, EtO or Irradiation sterilization)
Experience with In Vitro Diagnostic (IVD) manufacturing regulations
Background in a management position
Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.