Demo

Quality Project Manager

Katalyst Healthcares and Life Sciences
Minneapolis, MN Full Time
POSTED ON 1/16/2025
AVAILABLE BEFORE 4/13/2025

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 :

  • 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.
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