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QA/RA Associate

Company: Zeiss
Location: White Plains
Posted on: May 23, 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 closure
  • Assists process owners with development/review of Standard Operating Procedures for RMS and IQS
  • Provides 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 listings
  • Administers corporate document control process and updates QMS database
  • Administers Corrective Action/ Preventive Action System
  • Administers internal audit plan and scheduling
  • Prepares graphs or charts of data and/or analyzes data
  • Assist in internal and external audits
  • Participates in preparation of Management Review data and presentations
  • Other QA/regulatory duties and other duties as assigned
    • Bachelors Degree with 2 years experience in an ISO certified or QSR compliant environment
    • Working knowledge of FDA Quality System Regulation and CDRH reporting requirements
    • Working knowledge of ISO requirements, specifically ISO 9001 or ISO 13485 Medical Devices
    • ISO 9001 Auditor Certification a plus
    • Effective verbal and written communication skills
    • Strong Computer Skills (MS Word, Excel, PowerPoint, etc.)
    • Ability to schedule and handle multi-tasking to meet deadlines
    • Ability to interact positively and professionally at all levels of the organization
    • Ability to work independently or as part of a team The 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 About UsStep out of your comfort zone, excel and redefine the limits of what is possible. That's just what our employees are doing every single day - in order to set the pace through our innovations and enable outstanding achievements. After all, behind every successful company are many great fascinating people.
      In a spacious modern setting full of opportunities for further development, ZEISS employees work in a place where expert knowledge and team spirit reign supreme. All of this is supported by a special ownership structure and the long-term goal of the Carl Zeiss Foundation: to bring science and society into the future together.Diversity is a part of ZEISS. We look forward to receiving your application regardless of gender, nationality, ethnic and social origin, religion, philosophy of life, disability, age, sexual orientation or identity.Apply now! It takes less than 10 minutes.

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

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