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Job #03164

About our client Our client is privately owned medical device company headquartered in New Jersey that is focused on the development and commercialization of products in the area of coagulation. The company has an experienced management team, a robust line of products and an empowering corporate culture that is focused on the long-term professional development of its employees. Position Location Quality Assurance Analyst Parsippany, New Jersey Salary Highly competitive package, commensurate with experience Responsibilities 1) Create, review, write and coordinate efforts for the development and implementation of new and updated quality system procedures for QSR/ISO 2) Conduct reviews and proofing of various quality system related documentation (i.e. marketing literature, package inserts, protocols, etc.) 3) Track and follow up with remediation and implementation of CAPAs, non-conformances, change controls and various other related audits 4) Perform or assist in internal and/or external quality audits as well as the respective quality audit reports 5) Prepare presentations as assigned 6) Work with various project teams necessary for quality assurance Requirements 1) Bachelor’s degree in a related field from 4-year college or university 2) Internal auditing certificate preferred 3) Minimum 2 – 5 years of related QSR/GMP/GLP experience 4) Experience in QA with medical devices 5) Superb computer skills and knowledge of MS Office 6) Ability to present information logically and persuasively 7) Ability to write clearly and informatively 8) Ability to gather and analyze information skillfully