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 applications
Collaborate 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 investigations
Lead 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 guidance
Participate 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-up
The essential requirements of the job include:
Bachelor’s degree in science, engineering, medical or technical field
Proven experience in technical quality roles with increasing responsibility in medical device manufacturing, leading root cause investigations and structured problem solving using CAPA’s
Proficiency using Microsoft Office, including Word, Excel, and PowerPoint
Proficiency in English
Strong 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 teams
Travel % 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 Surveillance
Join 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 www.danaher.com.
Cepheid Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Cepheid and has not been reviewed or approved by Cepheid.
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Leave & Time Off Breadth — PTO and paid holidays are portrayed as robust, with formal programs and mentions of generous time off and rollover in some cases. This breadth supports a positive view of time-off availability.
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Healthcare Strength — Core medical, dental, and vision coverage is highlighted repeatedly and is viewed as comprehensive for regular full‑time employees. Descriptions such as “good” or “great” benefits reinforce the strength of the health coverage.
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Retirement Support — A 401(k) plan with company matching is consistently included as part of the package. The presence of matching contributions strengthens perceived retirement readiness.
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What We Do
Cepheid is dedicated to improving healthcare by pioneering molecular diagnostics that combine speed, accuracy, and flexibility. The company's GeneXpert® systems and Xpert® tests automate highly complex and time-consuming manual procedures, providing A Better Way for institutions of any size to perform world-class PCR testing. Cepheid’s broad test portfolio spans respiratory infections, blood virology, women’s and sexual health, TB and emerging infectious diseases, healthcare-associated infectious diseases, oncology and human genetics. The company’s solutions deliver actionable results where they are needed most – from central laboratories and hospitals to near-patient settings. For more information, visit http://www.cepheid.com.
