Quality Assurance Specialist Job at Medtronic Plc, United States

  • Medtronic Plc
  • United States

Job Description

Quality Assurance Specialist

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 95,000 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.

The Quality function at Medtronic Thailand supports the safe, effective, and compliant delivery of healthcare technologies by maintaining quality systems and ensuring adherence to internal policies, regulatory requirements, and external standards. The team partners closely with commercial, operations, supply chain, and third-party service providers to drive quality excellence, regulatory compliance, and continuous improvement across local operations. 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.

The Quality Assurance Specialist supports the implementation and maintenance of quality processes and compliance activities across Medtronic Thailand. This role partners with internal stakeholders and external service providers to ensure quality system effectiveness, support audit readiness, monitor compliance requirements, and contribute to the continuous improvement of operational quality standards that help maintain product availability and patient safety.

Primary Responsibilities

  • 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.

Required Qualifications

  • Bachelor's 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.

Preferred Qualifications

  • Experience in the healthcare, pharmaceutical, or medical device industry.
  • Experience supporting audits, inspections, or CAPA activities.
  • Knowledge of medical device regulations or GDP.

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.

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).

Job Tags

Temporary work, Local area, Remote work, Flexible hours

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