Overview
On Site
Full Time
Skills
NPI
IQ
OQ
PQ
Technical Support
Supervision
Quality Control
Assembly
Mechanical Engineering
Electrical Engineering
New Product Introduction
SolidWorks
Manufacturing
Documentation
Risk Management
FMEA
QMS
Corrective And Preventive Action
Auditing
ISO 13485
GMP
Windchill
Product Lifecycle Management
Plant Lifecycle Management
Communication
English
Job Details
Roles and responsibilities:
- NPI Validation, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), pFMEA and dFMEA.
- 3+ years of experience & demonstrated proficiency in New Product Introduction, Windchill PLM & providing ongoing technical support is preferred.
- Under limited supervision, performs and documents moderately complex technical functions relating to test, quality control, Client-out, fabrication, modification, and assembly of mechanical or electrical equipment and/or components.
- Experience in validation of product and equipment.
- Experience in New Product Introduction (NPD) with Solidworks.
- Knowledge of good manufacturing practices and documentation, preferably in the medical industry.
- Risk management experience pFMEA and dFMEA.
- Knowledge on QMS - NC, CAPA and contribution in audits and ETQ instinct experience if any.
- Preferably with knowledge of ISO 13485, FDA 21 CFR Part 820 and GMP.
- JnJ experience with ADAPTIV and Windchill PLM.
- Oral and written communication in English.
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