Katalyst CRO

Quality Project Manager

5 months ago

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Responsibilities

Working with other functional groups, including R&D and Operations in support of new product development, engineering projects, quality assurance activities, and lifecycle management.
Utilizing Quality Engineering tools/processes in development and implementation of practices for effective and efficient development.
Non-Conformance Report (Client) process for Streamed business unit.
Develop and establish effective quality control and support associated risk management plans, AFMEA, DFMEA and PFMEA.
Write, review and/or approve process and product validation protocols and reports, engineering change orders.
Use statistical tools to analyze data, make acceptance decisions, and improve process capability, Design Controls, Design of Experiments.
Technical problem solving, failure analysis, and root cause determination.
Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
Strong communication skills. Candidates must be highly proficient in reading, writing, and speaking English language.

Requirements:

A minimum with 5+ years of related experience Quality Management in Medical Device Industry.
Must Have Technical/Functional Skills- experience Required.
Knowledge of Medical procedure and corresponding Medical Equipment.
Good experience in CAPA execution, CAPA write up.
Good experience in Test Method Validation (TMV).
Good experience in Process Validation.
Knowledge of Medical Equipment manufacturing processes.
Knowledge on Quality Management and its tools & techniques.
Knowledge about FDA, ISO 13485, ISO 14971 and compliance regulations.
Knowledge on NC, Audit processes.
Knowledge in Statistic, Risk Management and Design control.
Must possess good communication skills (verbal and written), familiar with project management methodology, problem solving, and presentation skills.