Sr. Quality Engineer - Process Validation

Roles & Responsibilities:

Candidate must possess a bachelor's degree in engineering, or a scientific or quality assurance discipline.

wareness of Design controls and change controls for FDA regulated medical devices (21 CFR 820.20 and ISO13285 standards)

wareness 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.

bility 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.

bility to work remotely with advance proficiency in software applications: MS Office (Outlook, Word, Excel, PowerPoint, and MS Teams).

bility to work autonomously across functional boundaries to complete projects within required timeframes while being part of a team.