QA/RA Associate

Company: Zeiss Inc
Location: White Plains
Posted on: March 19, 2023

Job Description:

Join the Zeiss team in White Plains, NY, as a Quality Assurance/Regulatory Affairs (QA/RA) Associate. You will support the Quality Department in meeting regulatory obligations (e.g.: FDA reporting, Rad. Health reporting) and the maintenance of the various activities related to sustaining an ISO 9001/13485 Quality Management System including document control, complaint & CAPA processing, and audit planning. This is a Hybrid (3/2) position, working in the office, and remotely.Job Functions:Administers complaint process, including review and logging of incoming complaints, preliminary investigation and follow-up to closureAssists process owners with development/review of Standard Operating Procedures for RMS and IQSProvides Regulatory support, including guidance, review and preparation of filings for initial, supplemental and annual CDRH reports (including, but not limited to RMS, IQS, XRM, SBE, and SMT)Maintains FDA establishment registrations, renewals and device listingsAdministers corporate document control process and updates QMS databaseAdministers Corrective Action/ Preventive Action SystemAdministers internal audit plan and schedulingPrepares graphs or charts of data and/or analyzes dataAssist in internal and external auditsParticipates in preparation of Management Review data and presentationsOther QA/regulatory duties and other duties as assignedBachelors Degree with 2 years experience in an ISO certified or QSR compliant environmentWorking knowledge of FDA Quality System Regulation and CDRH reporting requirementsWorking knowledge of ISO requirements, specifically ISO 9001 or ISO 13485 Medical DevicesISO 9001 Auditor Certification a plusEffective verbal and written communication skillsStrong Computer Skills (MS Word, Excel, PowerPoint, etc.)Ability to schedule and handle multi-tasking to meet deadlinesAbility to interact positively and professionally at all levels of the organizationAbility to work independently or as part of a teamThe annual salary range for this contingent position (temp - to - hire) is $65 - 70K. The salary offered for this role may be influenced by factors such as job location, scope of role, qualifications, education, experience, complexity/specialization/scarcity of talent. Your ZEISS Recruiting Team:Steve Warner

Keywords: Zeiss Inc, White Plains , QA/RA Associate, Other , White Plains, New York