Sr. Quality Engineer - Katalyst Healthcares & Life Sciences
Santa Clara, CA 95050
About the Job
Responsibilities:
- Support internal and external audits for the RA organization.
- Manage CAPA activities and ensure timely resolution.
- Develop and maintain compliance-focused KPI dashboards.
- Identify risks and implement mitigation strategies to prevent nonconformities.
- Ensure adherence to medical device regulations (FDA, ISO 13485).
- Collaborate with international and cross-functional teams.
- Bachelor's degree in engineering, Quality, Life Sciences, or related field.
- 7+ years of experience in quality systems within the medical device industry.
- Experience with audits, CAPA management, and KPI dashboards.
- Strong communication, project management, and problem-solving skills.
Source : Katalyst Healthcares & Life Sciences