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.
