Website Katalyst Healthcares & Life Sciences
Katalyst Healthcares & Life Sciences
Company : Katalyst Healthcares & Life Sciences
Roles & Responsibilities:
- Lead and support design verification and validation activities, including test method development and execution.
- Perform sample size selection and statistical data analysis to support design decisions and risk assessments.
- Conduct process capability studies and support design transfer to manufacturing.
- Ensure compliance with FDA, ISO 13485, and other relevant regulatory standards.
- Collaborate with cross-functional teams including R&D, Regulatory, and Manufacturing.
- Review and approve design documentation including Design History Files (DHF),risk management files and test protocols.
- Provide technical guidance and mentorship to junior QEs offshore.
- Support CAPA investigations related to design issues and contribute to continuous improvement initiatives.
- Certified Quality Engineer (CQE) or equivalent certification.
- Experience with software tools such as Minitab, JMP, or similar statistical analysis platforms.
- Familiarity with risk management standards (ISO 14971) and usability engineering (IEC 62366).
- Good Knowledge of Medical Devices & QMS (ISO 13485, 21 CFR Part 820).