Senior Specialist, Quality Assurance And Regulatory Compliance
Danaher UK
Shanghai, China
Lead technical complaint investigations
Analyze customer complaint data
Apply iso 14971 risk management principles
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
Job Summary
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.
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.
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.
Matching Summary
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.
Skills & Requirements
Must-have
Lead technical complaint investigations
Analyze customer complaint data
Apply ISO 14971 risk management principles
Monitor complaint tracking systems
Collaborate with QC and R&D
Perform regulatory reporting globally
Participate in internal/external audits
Nice-to-have
Subject matter expertise in regulatory reporting
Influence change outside span of control
Build consensus with other departments
Key Requirements
Bachelor’s degree in science, engineering, medical or technical field
Proven experience in technical quality roles
Experience in medical device manufacturing
Leading root cause investigations
Structured problem solving using CAPA’s
Proficiency using Microsoft Office
Proficiency in English
Strong interpersonal, written and oral communications skills