Responsible for quality engineering support for the manufacturing of medical device throughout the supply chain.
Focuses on validation process review and risk management.
Using statistical techniques and quality tools to ensure medical devices are made in compliance with QMS, international & industry standards, regulatory requirements and customer requirements.
In charge of risk management process, maintain risk management procedure and risk management framework. Responsible for all risk assessment report review, review risk management plan/report for all product platforms.
Manage multiple projects to provide review on technical validation of analytical tests, control systems, utilities and manufacturing processes.
Driving overall quality performance and compliance throughout the organisation by defining, implementing validation program.
Develop and communicate expectations for quality performance, continuous improvement, quality systems, process controls infrastructure for critical sustaining parts and new products.
Drive manufacturing process improvement project to resolve quality, yield or cost reduction initiatives
Provide guidance or training on use of risk management tools and techniques, data analysis, sample size determination, problem solving methods and statistical control techniques.
Execute projects/other duties assigned by supervisor
Degree qualified in Science/Engineering major, with 3+ years of experience in Medical Device/Pharmaceutical industry handling validation process projects
Strong in Quality Assurance principles
Advanced skills in Validation principles / industry standards
Able to communicate & guide/train on validations, risk assessments and statistical techniques
Knowledge of ISO9001, ISO13485/21 CFR Part 820
We regret that only shortlisted candidates will be notified.
GMP Technologies (S) Pte Ltd | EA Licence: 11C3793 | EA Personnel: Tan Wai Peng | Registration No: R1104671