Overview
QA / Quality Systems Remediation Engineer (Medical Device – ISO 13485) Jobs in Latham, NY at Intellectt Inc
Title: QA / Quality Systems Remediation Engineer (Medical Device – ISO 13485)
Company: Intellectt Inc
Location: Latham, NY
Role Summary
We are seeking an experienced QA Remediation Engineer to support the transition from ISO 9001 certification to full ISO 13485 compliance within a medical device manufacturing environment. The role focuses on quality system remediation across the design transfer to manufacturing lifecycle, ensuring compliance readiness through structured gap assessments, risk analysis, and process validation activities.This is a fast-paced, cross-functional role requiring strong expertise in medical device quality systems and remediation initiatives.
Key Responsibilities
- Lead QA remediation efforts to bridge ISO 9001 to ISO 13485 compliance requirements
- Perform gap assessments between current QMS and regulatory standards
- Drive risk assessments and ensure proper documentation of mitigation plans
- Support design transfer to manufacturing processes from a quality perspective
- Oversee or contribute to process validation activities
- Collaborate with cross-functional teams (Engineering, Manufacturing, Regulatory, Quality)
- Ensure alignment with medical device regulatory expectations and audit readiness
- Support development and remediation of SOPs, work instructions, and quality records.
Required Experience
- 8–15 years of experience in Medical Device Quality / QA roles
- Strong background in QA remediation projects (mandatory)
- Hands-on experience with ISO 13485 implementation or transition
Expertise in:
- Quality systems and compliance
- Risk management
- Gap analysis and remediation planning
- Experience in design transfer to manufacturing
- Knowledge of process validation in medical device environments
- Ability to work in fast-paced, cross-functional project settings
