Rutherford, NJ, 07070, USA
40 days ago
QMS Auditor (Remote)
Job Description 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). We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com .     To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/ . Skills and Requirements 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 null We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to race, color, ethnicity, religion,sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military oruniformed service member status, or any other status or characteristic protected by applicable laws, regulations, andordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to HR@insightglobal.com.
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