Quality Engineer
Location
Blue Ash, Ohio
Job Type
Full-time
Category
other-general
Posted
May 14, 2026
Job Description:
Medical Device Quality Engineer with 4+ years of experience supporting Quality Management Systems (QMS) in regulated medical device and pharmaceutical environments. Experienced in complaint handling, CAPA, non-conformance investigations, post-market surveillance support, risk management, and regulatory compliance. Skilled in applying FDA 21 CFR Part 820, ISO 13485, and ISO 14971 standards to ensure quality-compliant project execution. Proven ability to collaborate with cross-functional teams, support audits and inspections, and manage quality deliverables across multiple projects within established timelines.
Roles & Responsibilities:
Medical Device Quality Engineer with 4+ years of experience supporting Quality Management Systems (QMS) in regulated medical device and pharmaceutical environments. Experienced in complaint handling, CAPA, non-conformance investigations, post-market surveillance support, risk management, and regulatory compliance. Skilled in applying FDA 21 CFR Part 820, ISO 13485, and ISO 14971 standards to ensure quality-compliant project execution. Proven ability to collaborate with cross-functional teams, support audits and inspections, and manage quality deliverables across multiple projects within established timelines.
Roles & Responsibilities:
- Support and maintain Quality Management System (QMS) processes in compliance with FDA regulations, ISO 13485, and medical device quality standards.
- Collaborate with cross-functional teams including Quality, Manufacturing, Regulatory Affair...