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Medical Device Auditor (Remote)

Company: A+ Personnel
Location: Bayonne
Posted on: March 27, 2020

Job Description:

A+ Personnel celebrates its 33rd Anniversary in the staffing industry in 2020! We have successfully been placing qualified candidates with top corporations, from entry to C-Level, in New Jersey and New York. We would like to thank our client companies and outstanding candidates for their major contribution to our continued success. We now look forward to assisting you with your next career move! Jill G. Rowland, President Please note: If this position is not for you, but you would like us to assist you with your next career move, please forward your resume with salary requirement Lead Medical Device Auditor To $90k Our client, a leader in their industry, needs your Auditor expertise! Responsibilities include: Perform audits as an auditor or lead auditor, in conformance with the company / Local procedures. Access and review North American clients medical devices quality systems and technical information to the requirements of ISO 9001, ISO 13485 and other regulatory requirements such as MDSAP, EU . Decide upon evidence gained during audits whether manufacturers meet the requirements of relevant standards / regulations, and if registration should be recommended. Respond to client inquiries on all technical matters regarding client certification / training products. Provide technical advice to those marketing and sales functions as required . Report any customer complaints, problems and or system deficiencies to the Director of Healthcare and Certification Management. Maintain competence and audit credentials by taking additional and/or refresher course(s), as necessary. Assist in the training of other auditors and lead auditors during planned audits or during other training functions. Participate actively in witness audits by company or accreditation bodies. Undertake any other activities as directed by the Director of Healthcare and/or Accreditation Manager. Requirements include: Bachelors degree in Science, Engineering or a related field. Min. 5 years of recent and relevant medical industrial experience or business experience. Possess an auditor certificate from a recognized organization is a plus Possess experience with medical device products in one or more of the following areas: radiation, neurological, soft tissue implant, absorbable products, orthopaedic, active therapeutic/diagnostic supplying energy, active administration, animal tissue etc. Strong background and knowledge of engineering and technical applications used in the development of medical devices. Global Regulatory Affairs background, including MDD / IVDD. Experience in FDA 510(k). Proactive attitude and excellent organizational skills . Effectively react in stressful situations and make clear, well-founded decisions regarding conformity during the audit. Ability to multitask and manage multiple projects while delivering results on time. Excellent interpersonal, verbal, written and presentation skills Ability to travel, including a valid driver's license If qualified, please forward your resume to: View all our opportunities at:

Keywords: A+ Personnel, Bayonne , Medical Device Auditor (Remote), Healthcare , Bayonne, New Jersey

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