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: