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.
Danaher Corporation Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Danaher Corporation and has not been reviewed or approved by Danaher Corporation.
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Healthcare Strength — Healthcare coverage is described as comprehensive, including medical plan options alongside dental, vision, life, disability, and mental health support. Wellness initiatives and support programs such as an EAP and vaccination or fitness offerings add breadth beyond core insurance.
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Retirement Support — Retirement benefits include a 401(k) plan with employer matching and options such as pre-tax and Roth contributions. Broader financial rewards such as performance bonuses and access to equity or an employee stock purchase plan are also described.
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Parental & Family Support — Parental leave and family-building support are described as available, including maternity and paternity leave and fertility assistance. Childcare and eldercare support are also highlighted as part of the overall package.
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What We Do
Danaher is a global science and technology innovator committed to helping our customers solve complex challenges and improve quality of life around the world. A global network of more than 25 operating companies, we drive meaningful innovation in some of today’s most dynamic industries through our operating companies in four strategic platforms: Life Sciences, Diagnostics, Water Quality and Product Identification. The engine at the heart of our success is the Danaher Business System (DBS), a set of tools that enables continuous improvement around lean, growth and leadership. Through the ingenuity of our people, the power of DBS and the impact of our meaningful technologies, we help realize life’s potential in ourselves and for those we serve.
