Dentsply Sirona is the world’s largest manufacturer of professional dental products and technologies, with a 130-year history of innovation and service to the dental industry and patients worldwide. Dentsply Sirona develops, manufactures, and markets a comprehensive solutions offering including dental and oral health products as well as other consumable medical devices under a strong portfolio of world class brands. Dentsply Sirona’s products provide innovative, high-quality and effective solutions to advance patient care and deliver better and safer dentistry. Dentsply Sirona’s global headquarters is located in Charlotte, North Carolina. The company’s shares are listed in the United States on NASDAQ under the symbol XRAY.

 

Bringing out the best in people

 

As advanced as dentistry is today, we are dedicated to making it even better. Our people have a passion for innovation and are committed to applying it to improve dental care. We live and breathe high performance, working as one global team, bringing out the best in each other for the benefit of dental patients, and the professionals who serve them. If you want to grow and develop as a part of a team that is shaping an industry, then we’re looking for the best to join us.

 

Working at Dentsply Sirona you are able to:

 

Develop faster - with our commitment to the best professional development.

 

Perform better - as part of a high-performance, empowering culture.

 

Shape an industry - with a market leader that continues to drive innovation.

 

Make a difference -by helping improve oral health worldwide.  

 

 

Dentsply Sirona, Waltham, MA, is looking for someone to join our Quality team as a Product Complaint Specialist.  

 

We offer competitive wages and a full menu of benefits including health (3 options), dental (provided), vision, life (provided) + extra life, short-term and long-term disability (provided), 401k (retirement) with company matching, 10 holidays and paid time off.

 

General Description of the Position:

The Complaint System Specialist is responsible to assist and provide support to establish, maintain, and continuously improve the Complaint Management System.

This position is responsible for supporting all aspects of the complaint management process including, but not limited to entry, review, investigation and reporting of all medical device complaint-related procedures, in accordance with applicable laws and regulations.

The Complaint System Specialist will provide support to ensure delivery of the safest and highest quality products while maintaining full regulatory compliance.  The Complaint System Specialist will ensure that the quality, safety, health and environment systems continue to meet FDA, ISO, MDD, CMDCAS, EPA, OSHA and other appropriate international and domestic standards and regulations.

 

Principal Responsibilities:

 

Perform & document urgency reviews. Evaluates information and determine if it qualifies as a complaint. Assesses complaint information provided, gathers any missing information for complainant file, and escalates complaint to appropriate parties as needed. Reviews potential reportable events to determine if regulatory filings are required. Ensures compliance with all federal and international regulations applicable to manufactured medical devices. Performs & documents complaint investigations. Documents and completes complaints promptly. Stays current with knowledge of and adheres to Quality systems. Interacts professionally with all organizational levels. Manages competing priorities in a fast-paced environment. Processes samples for decontamination as necessary. Responsible for monthly reporting activities.

Education/Experience:

High School Diploma or GED; BS in Engineering discipline preferred, or equivalent combination of education and experience 2-5 years of experience in Regulatory and/or Quality in a Medical Device / Regulated environment preferred Dental-Medical Device experience preferred Biomedical experience desired Working knowledge / basic understanding of statistical methods and project management.  Working knowledge / basic understanding of applicable domestic & international regulatory requirements and consensus standards preferred Strong knowledge of standard office tools like MS Office (Word, Excel, PowerPoint, Outlook)

Qualifications:

Plan and implement assigned projects and activities Extensive experience working in a team-oriented, collaborative environment Excellent oral and written communication and presentation skills Keen problem solving skills, ability to deal with complex situations and recommend a course of action Must be flexible and able to respond to rapid change to meet business needs Highly self-motivated and possess strong analytic and problem-solving acumen Ability to gather input from various sources and work independently. Ability to communicate easily in written and spoken English Cooperative attitude and ability to work in a time critical environment

 

 

 

Dentsply Sirona is an Equal Opportunity/ Affirmative Action 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.

If you need assistance with completing the online application due to a disability, please send an accommodation request to careers@dentsplysirona.com. Please be sure to include “Accommodation Request” in the subject.

 

For 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