Requistion ID : 77272

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.

The Product non-conformance & Quality Assurance Specialist plays an active role to ensure that Dentsply Sirona Quality Management System requirements are following the applicable policies, international standards and regulatory requirements concerning medical devices. This role does the coordination and has the ownership of occurring quality related activities and projects concerning (non-)product NC / MDR inspection / Pharma release within Venlo Distribution Centre.

ISO13485, GDP and EU-MDR Importer and Distributor processes are at the core of the activities!

The QA specialist collaborates with the local QA team and a variety of stakeholders within the local as well as international organization. Using good communication skills, the specialist plays an important role in taking ownership to handle and solve quality related topics and processes.

Product non-conformance & QA specialist, Venlo – the Netherlands

Responsibilities:

• Coordination of activities involving product nonconformity, MDR inspection and medicinal product releases including the monitoring and reporting

• Ensure compliance to EU-MDR Importer and Distributor responsibilities including verification obligations are completed on time

• Report any discrepancies, troubleshoot, and propose alternatives/improvements on processes. Play a key role in contributing and/or leading improvement projects

• Communicate and cooperate with coworkers and supervisors within our distribution center, Product Groups within Dentsply Sirona and other internal stakeholders

• Follow QMS procedures, always contribute to quality, proactively and on time

• Assist with monitoring and analyzing QMS processes for efficiency and improvement opportunities and implement actions to address identified gaps

• Participation in setting up, adjusting, and training SOP's and work instructions

• Guiding/mentoring/training/point of contact for colleagues in day-to-day activities in processes regarding (non-) product NC’s, MDR inspections and medicinal product releases

• Provide QA support in Value Added Services Labeling activities (documentation, change control, internal audit, intake of new activities and participate in projects, as required)

• Participate in QA activities such as change control, CAPA, and NC

• Follow safety procedures, report dangerous situations, incidents & accidents; contribute to safety as your first priority

Requirements and Qualifications:

• You have at least an MBO+/HBO degree in Business administration / Quality Assurance / Life Sciences or equivalent through experience.

• Proven working experience in a highly regulated Distribution/Manufacturing setting

• Proficiency in inventory software, databases and systems

• Familiarity with modern warehousing practices and methods

• Good organizational and time management skills

• Good command of the English language, spoken and written

• WMS experience (Movex, SAP, Manhattan, SmartSolve)

At Dentsply Sirona we offer a market conform salary, very attractive benefits and an informal working environment. We are a diverse workforce and are passionate about the work we do!

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 (careers@dentsply.com) . Please be sure to include “Accommodation Request” in the subject.