Analysis Skills, Corporate Policies, Cross-Functional, Data Quality, Document Control, Documentation, FDA (Food and Drug Administration), FDA Requirements, Maintain Compliance, Manufacturing, Medical Equipment, Metadata, Problem Solving Skills, Process Improvement, Quality Assurance, Quality Management, Quality Metrics, Regulations, Regulatory Compliance, Regulatory Requirements, Windchill PLM Software
Job Title :Quality Analyst
Location: NJ
Duration: Long Term
Job Summary
We are seeking a Quality Analyst Regulatory Compliance Specialist to support regulatory compliance activities and Quality Management System (QMS) processes within a medical device manufacturing environment. This role will work closely with the Regulatory Compliance team to ensure records, documentation, and quality systems remain compliant with applicable regulatory requirements.
Key Responsibilities
- Maintain and ensure accuracy of regulatory compliance records and documentation.
- Support Quality Management System (QMS) document control processes.
- Prepare, review, update, and maintain quality and regulatory records.
- Manage compliance-related database records and electronic systems.
- Identify and resolve discrepancies between metadata fields and approval records.
- Update Windchill records to ensure compliance and data integrity.
- Assist in developing and maintaining training materials and training audiences.
- Support process improvement initiatives and quality issue resolution activities.
- Ensure compliance with FDA regulations, company policies, and quality standards.
- Collaborate effectively with cross-functional teams and stakeholders..
Top Skills
- Regulatory Compliance
- Quality Management Systems (QMS)
- Medical Device Regulations
- Document Control
- Windchill
- FDA Compliance
- Quality Documentation
- Data Integrity
For more information, please reach out at 732-355-7246 or share your updated resume with rishitha.movva@intellectt.com