Senior Specialist, Quality Assurance and Regulatory Compliance

Shanghai
Permanent
Full-time

2 months ago

In this role, you will have the opportunity to:Lead technical complaint investigations with cross-functional teams, including analyzing complex customer complaint data to identify potential root cause trends and present to cross-functional audiences, including sales, marketing & engineering personnel; applying principles of risk management in accordance with ISO 14971 in order to prioritize the criticality of customer complaints and to determine MDR reportability; and monitoring and improving tracking/control systems for complaint handling and MDR reporting using Microsoft Excel or other software applicationsCollaborate with Quality Control and Research and Development personnel on physical evaluation of returned complaint product, ensuring sound scientific experimental planning and recommending applicable statistical sample sizes in accordance with industry standards; approve technical scientific reports for complaint investigationsLead the investigations for the highest risk complaints and perform the regulatory reporting as required globally (for example, MDRs, MIRs, etc.)Provide a high level of subject matter expertise to the organization in regulatory reporting guidanceParticipate in performance and documentation of internal and external audits in accordance with internal and supplier auditing schedules, respond to audit findings by proposing and implementing necessary corrective actions, and support Field Corrective Action responses via data compilation and customer follow-upThe essential requirements of the job include:Bachelor’s degree in science, engineering, medical or technical fieldProven experience in technical quality roles with increasing responsibility in medical device manufacturing, leading root cause investigations and structured problem solving using CAPA’sProficiency using Microsoft Office, including Word, Excel, and PowerPointProficiency in EnglishStrong interpersonal, written and oral communications skills, including ability to explain complex information to others, influence change outside of the local span of control, and build consensus with other departments and project teamsTravel % of Travel, include approximate overnight stays per week

Travel expectations for this role is limited and mainly flexible (10%)

Location:

This is part of the Global Post Market Surveillance team located in Shanghai, China and will be an on-site role.

Reporting to:This position reports to the Director, Post Market SurveillanceJoin our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.For more information, visit .

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