QA/RA Associate
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
- Rate: Not Specified
- Location: White Plains, US-NY
- Type: Permanent
- Industry: Finance
- Recruiter: Zeiss Group
- Contact: Not Specified
- Email: to view click here
- Reference: JR_1005834
- Posted: 2024-08-27 08:14:27 -
- View all Jobs from Zeiss Group
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