Senior Quality Assurance Design Engineer - Katalyst Healthcares & Life Sciences
Middletown, VA 22645
About the Job
Responsibilities:
- Apply and implement IVDR 2017/746 and ISO 13485 standards.
- Create and maintain DHF and manage design control processes.
- Develop and maintain quality management system records for regulatory compliance.
- Participate in regulatory audits, ensuring compliance with procedures.
- Conduct compliance assessments, identify gaps, and develop action plans.
- Lead quality training programs and support internal audits.
- Continuously improve the quality management system to meet evolving standards.
- Experience in DHF procedures, mitigation strategies, and timeline management.
- Background in biology or chemistry for IVDR technical file remediation.
- Strong knowledge of IVDR 2017/746, ISO 13485, DHF creation, and design control processes.
- Provide reports, analysis, and feedback on compliance and KPIs.
Source : Katalyst Healthcares & Life Sciences
