What are the responsibilities and job description for the Senior Quality Engineer position at Katalyst Healthcares and Life Sciences?
Responsibilities :
- Candidate mssess a bachelor's degree in engineering, or a scientific or quality assurance discipline.
- Awareness of Design controls and change controls for FDA regulated medical devices (21 CFR 820.20 and ISO13285 standards)
- Awareness of Test Method Validation, Installation Qualification, and related Statistics : Study design, DOE, TM Characterization, Data Analysis (Gage R&R, Correlation, etc.), Test method validation study.
- Ability to create technical documentation including TMC, IQ, TMV, and Generic Verification protocols and reports.
- Understanding of test fixtures and test equipment such as tensile frames.
- Excellent written and oral communications. Ability to summarize and consolidate data and information in presentation form for cross-functional discussion.
- Ability to work remotely with advance proficiency in software applications : MS Office (Outlook, Word, Excel, PowerPoint, and MS Teams).
Requirements :
