Perform Validation Process review and Risk Management
Utilize appropriate statistical techniques and quality tools to ensure medical devices are made in compliance with QMS, international/quality standards, regulatory and customer requirements.
In-charge of risk management process, maintain risk management procedure and framework.
Responsible for all risk assessment report review, review risk management plan/report for all products platform
Drive overall quality performance and compliance throughout the organization by defining and implementing validation program
Develop and communicate expectations for quality performance, continuous improvement, quality systems, process control infrastructure for critical sustaining parts and new products
Drive manufacturing process improvement project to resolve quality, yield or cost reduction initiatives driven by the organization
Provide guidance or training on the use of risk management tools and techniques
Execute projects and other duties that determined by supervisor
Requirements:
Degree or Diploma Holder in any relevant science or engineering field
At least 3 years QA experience in medical device or pharmaceutical industries; Strong fundamental knowledge on QA principles
Working knowledge on Validation process, principles and guidelines
Injection Molding and Sterilization process experience are added advantage
Strong fundamental knowledge on QA principles
Ability to communicate across functional team on guidance for validation, risk assessment, and statistical techniques.
Knowledgeable in ISO 9001, ISO 13485 and/or 21 CPR Part 820 regulations
Excellent written and verbal communication
Meticulous and detail-oriented
Confident to lead a constructive debate about product quality with colleagues and suppliers
To apply, please visit to www.gmprecruit.com and search for Job Reference:15346
To find out more about this opportunity, please contact Alexandra Calingo at: alexandra@gmprecruit.com
GMP Recruitment Services (S) Pte Ltd | EA Licence: 09C3051 | EA Personnel: Alexandra Calingo | Registration No: R1101491
