? Set up the Quality Systems to it meets Singapore, China and requirement countries requirement.
? Establishes quality programs and initiatives to ensure products and assemblies are developed and manufactured per applicable requirements.
? Establish strong supplier control and Quality oversight over suppliers and Medtronic entities.
? Driving continual and preventive improvement of quality management systems in supporting the conformity of process and product quality.
? Supports and develops systems for the identification, analysis, correction, and prevention of quality issues.
? Contributes quality expertise to product development and manufacturing transfers including working closely with suppliers to implement robust manufacturing processes and Quality oversight.
? Oversees and lead key quality systems processes to ensure its effectiveness which includes Design Control, Supplier Controls, Quality Planning, Document Controls, Training, Audits, Change Controls, Nonconformance CAPA, Manage External Requirement, etc.
? Leads the site audit readiness and manages, conducts and coordinates external (Singapore, China, ISO, etc.) audits.
? Take preventive actions to improve the compliance and effectiveness of Quality Management Systems by proactive learning from other sites and best practices from the industry.
? Provides QA support, participate and collaborate with Operating Units improvement program
? Works with local management team members in developing long and short-term quality goals and strategies.
? CAPA board member
o Participate in CAPA and board meetings to review the trending of all input sources and determine if any further action is needed
o Perform review on the CAPA investigation, action plan and effectiveness to determine if CAPA process requirement are fulfilled.
? Represents the new entities to collaborate with peers across all Operating Units for global quality initiatives and works closely with peers on similar quality concerns between Medtronic sites

• Bachelors Degree required
• Minimum of 5 management expertise in the Pharmaceutical, Medical Devices or any highly regulated commercial Quality and manufacturing industry.
Your Profile:
• Familiar with Singapore medical device requirement, China Good Manufacturing practices, ISO13485 and knowledge of Quality System Regulations.
• Training in the following will be advantaged:
- Singapore HSA (Health Science Authority)
- ISO Standards
- Basic Statistics
- Quality Auditing
- Continuous Quality Improvement Methods
- China GMP
• Effective interpersonal, communication and influencing skills
• Effective listening and writing/technical skills