Website Katalyst Healthcares & Life Sciences
Katalyst Healthcares & Life Sciences
Company : Katalyst Healthcares & Life Sciences
Job Summary:
We are seeking a highly experienced Quality Engineer IV to support quality systems compliance within the medical device industry.
This role focuses on managing quality systems integration, regulatory support, CAPAs, and audits.
The position is 100% onsite, and local candidates will be prioritized.
Candidates must be open to contract roles only.
Key Responsibilities:
Support and maintain quality systems to ensure regulatory compliance (ISO 13485, 21 CFR Part 820, EU MDR)
Manage CAPAs, non-conformances, and prepare for audits
Lead projects related to quality systems integration and KPI dashboard management
Ensure labeling controls and documentation alignment with regulatory requirements
Support regulatory teams for compliance efforts (not involved in product submission
Requirements:
Bachelor’s degree in science or engineering.
7+ years of experience in the medical device industry.
Strong understanding of quality systems, regulatory standards, and audit processes.
Proven experience in CAPA management and quality system integration.
Experience supporting quality-related efforts during company transitions or acquisitions is a plus.