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: