Senior Specialist, Quality Assurance And Regulatory Compliance
Danaher
Shanghai, China
Lead technical complaint investigations
Risk management in accordance with iso 14971
Regulatory reporting globally (mdrs, mirs)
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
Risk management in accordance with ISO 14971
Regulatory reporting globally (MDRs, MIRs)
Physical evaluation of returned complaint product
Internal and external audits
Corrective actions implementation
Nice-to-have
Explain complex information to others
Influence change outside of local 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
Proficiency using Microsoft Office
Proficiency in English
Strong interpersonal, written and oral communications skills