Quality Assurance Specialist
Job Summary
Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain restore health and extend life. Our 95000 employees work across more than 150 countries to put patients first developing innovative medical technologies that improve the lives of 72 million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose growth and impact.
This position is based in Bangkok Thailand and follows a Flex work model. Occasional travel of approximately 20% is required primarily to support activities at local warehouse and operational sites.
- Support the development implementation and maintenance of quality programs processes and procedures to ensure compliance with applicable regulations and internal standards.
- Monitor quality system activities and provide guidance to stakeholders on quality requirements policies and procedures.
- Conduct quality oversight of operational processes and third-party service providers to ensure adherence to established quality standards.
- Coordinate audit and inspection readiness activities including preparation of documentation stakeholder alignment and follow-up of corrective actions.
- Prepare and maintain quality records reports corrective and preventive action (CAPA) documentation and other compliance-related documentation.
- Collaborate with cross-functional teams to investigate quality issues identify root causes and support implementation of corrective actions.
- Support responses to regulatory inquiries legal requests government investigations or compliance-related reviews as required.
- Contribute to continuous improvement initiatives that enhance quality system effectiveness and operational compliance.
- Bachelors degree with 2 years of experience in Quality Assurance Quality Systems Regulatory Compliance or a related quality function.
- Knowledge of quality management systems and compliance requirements.
- Experience maintaining quality documentation and records.
- Experience in the healthcare pharmaceutical or medical device industry.
- Experience supporting audits inspections or CAPA activities.
- Knowledge of medical device regulations or GDP.
Physical Job Requirements
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position but they are not an exhaustive list of all the required responsibilities and skills of this position.
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Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits resources and competitive compensation plans designed to support you at every career and life stage.
Required Experience:
IC
About Company
About Medtronic Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an excit ... View more