• Global Medical Device MNC
• Work Location: West
• Multiple vacancies available

Responsibilities:

• 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 Technologies (S) Pte Ltd | EA Licence: 11C3793 | EA Personnel: Alexandra Calingo | Registration No: 09C3051