Quality Engineer - Medical Devices

Description

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
A minimum with 5+ years of related experience Quality Management in Medical Device Industry.
Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, the duties and responsibilities for this position are
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 the effective and efficient development.
Non-Conformance Report (Client) process for Sterilmed 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 analyse 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.