Job Title: Medical Device Technical Writer Location: Rahway, NJ or West Point, PA (Hybrid) Hours/Schedule: Mon- Fri 8am- 5pm Type: Contract Overview Global Pharma company looking to hire an experience Technical Writer to join their team. Must have experience with Medical Devices, technical assessments and writing of change controls, and a BS Degree. This is not an IT role. Responsibilities The basic function of this position is to author technical change assessment related to medical devices and to provide support to customer complaints – including ensuring the root cause appropriately considers the device and device constituents, author technical and risk assessment related to the device design change, and document the device risk analysis from complaints. Team supports multiple Medical Device and Combination Products (MDCP), such as vaccine prefilled syringes and devices. Requirements Bachelors in Science, Engineering or related field. Can be a mix of Co-op and real world experience (3-5 years). Has experience in authoring design control documentations per 21 CFR 820.30 or device risk document per ISO 14971. Demonstrated interpersonal skills including flexibility and ability to work in a team environment. Proven analytical abilities. Work requires experience in engineering change assessment, root cause investigations and device risk document management. Demonstrated interpersonal skills including flexibility and ability to work in a team environment. The candidate will work with a small team that supports life-cycle management activities of medical device combination products. Proven problem solving abilities. Demonstrated written and verbal communication skills. Preferred skillsets- Medical device combination product background/experience, understanding root cause, deviation management and change management. Benefits System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan. Joulé
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