Global Complaints Specialist
Dentsply Sirona, Waltham, MA, United States
Job Summary
We are seeking a detail‑oriented and highly motivated Global Complaint Specialist to join our Global Complaint Handling Unit – Post Market Surveillance team. This position plays a key role in ensuring timely and accurate disposition, intake and documentation of product complaints, supporting regulatory compliance, and collaborating across functions to enhance product quality and customer satisfaction. The ideal candidate brings a strong sense of accountability, excellent communication skills, and a desire to grow within the medical device and pharmaceutical industries.
Responsibilities
Serve as the primary complaint initiator for the Global Complaint Handling Unit.
Accurately receive, evaluate, codify, and document product complaints in the designated complaint management system, ensuring all required data is captured in a timely and compliant manner.
Conduct follow‑up communication with complainants to support investigations and gather additional information as needed.
Provide regular updates on complaint status and, when applicable, communicate final investigation findings to the complainant in a professional and empathetic manner.
Ensure all complaint‑handling activities are performed in accordance with applicable global regulations and standards, including but not limited to 21 CFR 820, 21 CFR 803, ISO 13485:2016, and EU MDR (Regulation EU 2017/745).
Adhere to internal policies, SOPs, and quality system requirements.
Contribute to the investigation process by collaborating with internal teams and supporting documentation efforts.
Participate in root cause analysis and recommend next steps as appropriate.
Support the implementation of corrective or preventive actions stemming from complaint data, helping to reduce the likelihood of recurrence.
Assist in tracking and trending complaint data and prepare reports and data insights to support ongoing quality improvement initiatives.
Provide guidance and share best practices with internal teams on complaint handling processes.
Support onboarding and training of new team members as needed.
Partner with teams such as Engineering, Manufacturing, Regulatory Affairs, and Customer Service to resolve complaints effectively and drive continuous improvement.
Perform other responsibilities as assigned in support of team and departmental goals.
Education
High School diploma or equivalent required.
Associate’s or Bachelor’s degree in a scientific, technical, or healthcare‑related discipline preferred.
Experience
1–3 years of experience in a customer‑facing or highly regulated role preferred.
Experience in a medical device, pharmaceutical, or other life sciences industry is a strong plus.
Key Skills, Knowledge, and Capabilities
Proficient in English; strong written and verbal communication skills required.
Multilingual abilities are highly desirable.
Excellent organizational skills and a high degree of attention to detail are fundamental to success.
Strong comfort level with computer‑based tasks, including working across multiple systems or screens simultaneously.
Proficiency in standard office software (e.g., Microsoft Office Suite); experience with electronic quality or complaint management systems preferred.
Able to work both independently and collaboratively in a fast‑paced, team‑oriented environment.
Familiarity with regulated environments and an understanding of global regulatory frameworks preferred.
Occasional travel may be required ( Equal Opportunity Employment Dentsply Sirona is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, disability, or protected Veteran status. We appreciate your interest in Dentsply Sirona.
California Residents We may collect the following categories of personal information in connection with the submission of your resume or application materials to us for employment, and if hired, your employment with us: identifiers (e.g., name, address, email address, birthdate); personal records (e.g., telephone number, signature, education information, criminal background information, passport number and visa information); consumer characteristics (e.g., sex, marital status, veteran status, race, disability, sexual orientation); professional or employment information (e.g., resume, cover letter, employment history, background check forms, references, certifications, transcripts and languages spoken); and inferences from personal information collected (e.g., a profile reflecting abilities and aptitudes). The above categories of personal information are collected for the following business purposes: performing recruitment and hiring services; processing interactions and transactions (e.g., to comply with federal and state laws requiring us to maintain certain records, managing the workforce); and security (e.g., detecting security incidents, protecting against fraudulent or illegal activity). For additional details and questions, contact us at careers@dentsplysirona.com.
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Responsibilities
Serve as the primary complaint initiator for the Global Complaint Handling Unit.
Accurately receive, evaluate, codify, and document product complaints in the designated complaint management system, ensuring all required data is captured in a timely and compliant manner.
Conduct follow‑up communication with complainants to support investigations and gather additional information as needed.
Provide regular updates on complaint status and, when applicable, communicate final investigation findings to the complainant in a professional and empathetic manner.
Ensure all complaint‑handling activities are performed in accordance with applicable global regulations and standards, including but not limited to 21 CFR 820, 21 CFR 803, ISO 13485:2016, and EU MDR (Regulation EU 2017/745).
Adhere to internal policies, SOPs, and quality system requirements.
Contribute to the investigation process by collaborating with internal teams and supporting documentation efforts.
Participate in root cause analysis and recommend next steps as appropriate.
Support the implementation of corrective or preventive actions stemming from complaint data, helping to reduce the likelihood of recurrence.
Assist in tracking and trending complaint data and prepare reports and data insights to support ongoing quality improvement initiatives.
Provide guidance and share best practices with internal teams on complaint handling processes.
Support onboarding and training of new team members as needed.
Partner with teams such as Engineering, Manufacturing, Regulatory Affairs, and Customer Service to resolve complaints effectively and drive continuous improvement.
Perform other responsibilities as assigned in support of team and departmental goals.
Education
High School diploma or equivalent required.
Associate’s or Bachelor’s degree in a scientific, technical, or healthcare‑related discipline preferred.
Experience
1–3 years of experience in a customer‑facing or highly regulated role preferred.
Experience in a medical device, pharmaceutical, or other life sciences industry is a strong plus.
Key Skills, Knowledge, and Capabilities
Proficient in English; strong written and verbal communication skills required.
Multilingual abilities are highly desirable.
Excellent organizational skills and a high degree of attention to detail are fundamental to success.
Strong comfort level with computer‑based tasks, including working across multiple systems or screens simultaneously.
Proficiency in standard office software (e.g., Microsoft Office Suite); experience with electronic quality or complaint management systems preferred.
Able to work both independently and collaboratively in a fast‑paced, team‑oriented environment.
Familiarity with regulated environments and an understanding of global regulatory frameworks preferred.
Occasional travel may be required ( Equal Opportunity Employment Dentsply Sirona is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, disability, or protected Veteran status. We appreciate your interest in Dentsply Sirona.
California Residents We may collect the following categories of personal information in connection with the submission of your resume or application materials to us for employment, and if hired, your employment with us: identifiers (e.g., name, address, email address, birthdate); personal records (e.g., telephone number, signature, education information, criminal background information, passport number and visa information); consumer characteristics (e.g., sex, marital status, veteran status, race, disability, sexual orientation); professional or employment information (e.g., resume, cover letter, employment history, background check forms, references, certifications, transcripts and languages spoken); and inferences from personal information collected (e.g., a profile reflecting abilities and aptitudes). The above categories of personal information are collected for the following business purposes: performing recruitment and hiring services; processing interactions and transactions (e.g., to comply with federal and state laws requiring us to maintain certain records, managing the workforce); and security (e.g., detecting security incidents, protecting against fraudulent or illegal activity). For additional details and questions, contact us at careers@dentsplysirona.com.
#J-18808-Ljbffr