Requistion ID : 77406

A smile can be transformative. Byte was founded on a commitment to improve access to orthodontic care through its affordable, easy-to-use, direct-to-consumer clear aligner solution. We celebrate every customer’s newfound confidence from their beautiful smile because our customers are at the heart of everything we do. Now a part of Dentsply Sirona with its unmatched resources and R&D capabilities, we are growing our team in the US to reach new customers and accelerate our mission of changing the world one smile at a time.

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, USA. The company’s shares are listed in the United States on NASDAQ under the symbol XRAY.

About byte.

We are an ambitious team that is transforming the way people achieve a beautiful, more confident smile. No longer do you have to step inside the orthodontist office to create the smile of your dreams. With a click of a button, you are on the road to making those dreams a reality. Our doctor-directed, at-home system makes it easy, safe, and affordable for everyone.

We also believe that a job should do more than pay the bills. It should fill you with a sense of purpose. The kind you feel when you’re a part of something BIG.

Interested? Let’s talk.

The primary job responsibility for the Complaint Administrator is overseeing the day-to-day functions of Dentsply Sirona OASG custom made product complaint handling activities. This includes, but is not limited to independently accepting, reviewing, and processing, product complaints communicated from both internal and external sources. In addition, this position is to ensure product complaints received are documented, reviewed, investigated, trended, and resolved in a timely manner in accordance with defined timeframes. Furthermore, this position acts as the owner for the monthly Product Surveillance Committee meeting by compiling the presentation from all completed quality metrics to discuss in front of a cross-functional team of subject matter experts and organization leadership

Key Responsibilities

• Reviews all product complaints entered into the complaint handling data base by Customer Service/Sales, to ensure accuracy of the data entered to include but not limited to the product indicated aligns with the complaint statement made by the customer.

• Evaluates, assigns investigation(s), and tracks timely completion and closure of complaints.

• Ensures the integrity and completeness of Complaint Files prior to closure.

• Responsible for reviewing all product complaints to differentiate between serious and non-serious complaints and determine reportability to worldwide regulatory agencies within the required timeframes.

• Reviews and approves complaints and complaint closure information for completeness using Good Documentation Practices while interpreting and analyzing statistical data to identify trends.

• Oversees product complaint investigations to resolution while ensuring documentation of clear, complete, and timel investigations that are supported by data in accordance with company procedures and regulatory compliance.

• Responsible for assuring timely review and closure of complaints while maintaining efficient workflow, work assignments and throughput.

• Ensures accurate documentation of evaluation and investigation results with the assigned complaint records.

• Has primary responsibility in overseeing the complaint handling data base in accordance with documented procedures to ensure data integrity, regulatory compliance, and customer satisfaction.

• Reviews global medical device complaints for the identification of reportable events in the local countries and for any reciprocal reporting requirements within the required timeframes including but not limited to Medical Device Reports (MDR) and Medical Device Incident Reports (MDIR).

• Responsible for the submission of US MedWatch reports and ensuring US reportable events are reviewed prior to submission and submitted within the required timeframes.

• Prepares formal reports for adverse event complaint responses to regulatory authorities.

• Run daily/weekly reports to track progress of reporting activities and to review new incoming information for any changes to reportability of a compliant.

• Interacts with cross functional teams to obtain additional information of the alleged event as necessary to ensure completeness of all required appropriate forms and to communicate complaint investigation results, product return inquires and complaint closure information as required by corporate procedures and guidelines.

• Collaborate with Engineering, Customer Support, Field Sales, Marketing, and other appropriate groups for adequate evaluation of complaints.

• Summarizes the results of data analysis and investigations into clean, concise complaint documentation, presentations, and reports for peers, cross-functional teams, and management. This includes but is not limited to:

• Sort all complaints into their correct category

• Total complaints received and associated complaint rates

• Responsible for the coordination of worldwide complaint data into appropriate management reports, analyzing trend data associated with complaints, drawing appropriate conclusions to trend data, and presenting such data in a meaningful, usable format to management.

• Summarize data to support post market surveillance reporting, regulatory responses, and external audits.

• Communicates directly with Dentsply Sirona Corporate QA/RA concerning all serious complaints within defined timeframes.

• Generates nonconformances and/or Corrective and Preventative Actions (CAPA) in association with substantiated product complaints for both internally and externally manufactured product.

• Tracks and reports on quality and measurements and metrics concerning complaints.

• Supports documentation, and closure of field correction and removal (recall) activities, as required.

• Creates detailed trend analysis reports showing product complaints by category and product to be utilized for PSC presentation, monthly reporting and/or special investigation purposes as requested.

• Escalates any new, unknown risk or hazards for further evaluation and decisions

• Supports the development of draft Health Hazard Evaluations (HHEs) associated with product complaints received with potential risk to end users and/or their patients.

• Ensures electronic complaint system is up to date with the most current SKU’s and associated data.

• Acting Document Control Coordinator (DCC) for the Mexicali location and back-up DCC for DS Orthodontics.

• Maintains up-to-date training compliance via LMS.

• Develops team culture to provide an optimum environment for employees’ growth and contribution.

• Develops and revise all applicable standard operational procedures, work instructions, forms etc. to meet corporate, regulatory and ISO requirements and optimize the quality management system as required.

• Documents quality data using good documentation practices both manually and electronically, ensuring all quality data is in a retrievable state to support continuous improvement activities.

• Additional assignments as assigned

Requirements and Qualifications

• HS Graduate and some college preferred

• 3-5+ years of manufacturing, quality assurance, and/or engineering experience preferred.

• Working knowledge of US medical device regulations (21 CFR Parts 820, 803, and 806) preferred.

• Working knowledge of standard quality system requirements (ISO13485, Medical Device Directive, Canadian Medical Device Regulation, MDSAP) preferred.

• Prior experience as an internal auditor preferred.

• Ability to assess risks, and where appropriate, recommend contingency plans and strategies to mitigate risks;

• Strong problem-solving skills and ability to make firm decisions.

• Highly motivated self-starter with the ability to function in a fast-paced team-oriented environment with minimal supervision.

• Must have excellent problem solving, time management, organizational, and interpersonal skills, with the ability to work independently.

• Ability to deal with a variety of variables in situations where limited information exists.

• Ability to manage conflict.

• Ability to articulate thoughts and ideas effectively through both written and oral communication.

• Proficient in Microsoft Office software, including Outlook, Word, Excel, and PowerPoint, as applicable.

• Microsoft Dynamics AX knowledge preferred.

• Ability to perform effective investigational and root cause activities.

• Ability to multitask and prioritize work to meet defined timeliness requirements.

• Must be detailed oriented and well organized

Perks

• Competitive base pay

• Health, Vision and FREE dental plan

• Generous Paid Time Off and (10) Paid Holidays a year

• Matching 401(k) program

• Employee Stock Purchase Program

• Paid Parental Leave

• Tuition Reimbursement

• Awesome aligner and whitening benefits for you and your family

• And a variety of personal assistance programs to help enrich your life in and out of the office

The base salary and variable compensation for this role is between $45,000 and $56,000. Actual compensation is influenced by a wide array of factors including but not limited to skill set, level of experience, and specific office location.

Dentsply Sirona is an Equal Opportunity employer committed to fairness, diversity and respect.

As such, all qualified applicants will receive consideration for employment without regard to age, national origin or any other characteristic protected by law.

Please note that all applications must be completed using the online form.