Overview
Quality Engineer Jobs in United States at United Pharma Technologies Inc
Title: Quality Engineer
Company: United Pharma Technologies Inc
Location: United States
Job Description: Quality Engineer
Location: Remote
Project Overview:
Our client is seeking skilled Quality Engineers (QEs) to join their team for a two-year DHF (Design History File) Remediation project.
Key Responsibilities:
Perform DHF remediation activities, including the review, update, and management of design history records to ensure compliance with regulatory and quality standards.
Manage and process quality documentation within The Vault, ensuring accuracy, completeness, and alignment with project requirements.
Conduct gap assessments on existing quality documentation and implement corrective actions to close identified gaps.
Review and update risk management files, design verification and validation documents, and other DHF records.
Collaborate with cross-functional teams, including Development Engineers, Regulatory Affairs, and Quality teams, to ensure alignment on remediation efforts.
Ensure compliance with FDA, ISO 13485, and other applicable regulatory requirements.
Support internal and external audits by providing necessary documentation and evidence.
