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
QA/RA Associate
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 Regulator...
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