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