Senior Specialist, Quality Assurance and Regulatory Compliance

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