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.
Beckman Coulter Diagnostics Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Beckman Coulter Diagnostics and has not been reviewed or approved by Beckman Coulter Diagnostics.
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Healthcare Strength — Healthcare coverage is described as comprehensive, including medical, dental, vision, life and disability insurance, flexible spending accounts, and mental health support. Feedback suggests these offerings are a notable strength of the overall package.
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Leave & Time Off Breadth — Paid time off, paid holidays, sick days, and volunteer time are highlighted, with flexibility or remote arrangements available for some roles. Feedback suggests this breadth of time-off options contributes meaningfully to total rewards.
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Parental & Family Support — Paid parental leave is provided for birth, adoption, or foster placement with the ability to use time in flexible increments within the first year. Feedback suggests family-focused perks like adoption support add tangible value for caregivers.
Beckman Coulter Diagnostics Insights
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What We Do
Beckman Coulter is committed to advancing healthcare for every person by applying the power of science, technology, and the passion and creativity of our teams to enhance the diagnostic laboratory’s role in improving healthcare outcomes. Our diagnostic systems are used in complex biomedical testing, and are found in hospitals, reference laboratories and physician office settings around the globe. Beckman Coulter offers a unique combination of people, processes and solutions designed to elevate the performance of clinical laboratories and healthcare networks. We do this by accelerating care with a menu that matters, bringing the benefit of automation to all, delivering greater insights through clinical informatics and unlocking hidden value through performance partnership. An operating company of Danaher Corporation since 2011, Beckman Coulter is headquartered in Brea, Calif., and has more than 11,000 global associates working diligently to make the world a healthier place.
