Imperative Care, Inc – $138,258.00/Year

MINIMUM REQUIREMENTSbr B.S. in bioengineering, biomedical engineering or related engineering field and 5 years of work experience in a medical device, or related regulated industry experience, or a M.S. in bioengineering, biomedical engineering or related engineering field and 3 years of work experience in a medical device, or related regulated industry experience.br Experience with development and validation of test methods to comply with at least one of the following recognized standards OSHA, GLP, APLAC, ASTM, ISO.br Experience addressing supplier or process issues CAPAs, NCMRNCRs,br SCARs, etc.br Must be knowledgeable about quality system requirements FDA 21 CFR Partbr 820, ISO 13485 or ISO 9001, risk management standards ISO 14971 and goodbr manufacturing practicesbr Excellent communications skills both written and verbalbr Must be able to provide thorough and meticulous review of documents.br Must be able to write clear, concise, and well thought out technicalbr documentation with a focus on failure investigations and inspection procedures.br Must be able to perform multiple tasks concurrently with accuracybr Proficiency with Microsoft Office products.