Senior Quality Assurance Specialist - Venlo, Netherlands

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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 Senior Quality Assurance Specialist supports the expansion of EU-MDR related Importer & Distributor Quality Management System (QMS) set-up and processes aligned to business operating model harmonization programs. The role acts independently as a liaison for the EU Distribution Centers in change processes regarding QMS, Value Added Services and Continuous Improvements. This will be in such a way that the organization keeps meeting the Legal, Corporate and ISO 13485 requirements. This role contributes to a further standardized and structured approach within Dentsply Sirona, the EU Distribution Center and QARC processes. The specialist will also make sure that all external and internal Stakeholders are aware and acting according to their roles and responsibilities.

Senior Quality Assurance Specialist - Venlo, Netherlands
This is a temporary role of 12 months

Key Responsibilities :

• Ensure compliance with the ISO13485 based Quality Management System, in accordance with Dentsply Sirona Policy, applicable worldwide regulations and standards (e.g. EU MDR, FDA and ISO)
• Assist with implementing and maintaining a single Dentsply Sirona Global Distribution Management System (QMS) strategy at sites connected to the Hub & Spoke Distributor network.
• Coordinate with suppliers the follow-up of projects and quality initiatives to achieve the quality requirements and the stability of the processes. Define action plans to implement the needed improvements, based on the results.
• Evaluate supplier quality performance metrics and initiate investigations into trends or repetitive events as required. Report information to appropriate areas of the business (i.e. Purchasing and Operations), as well as the suppliers.
• Implementation of quality related supplier controls including audit. Maintenance and improvement of the KPI monitoring for suppliers. Work with sites to implement containment activities and corrective action plans when resolving issues.
• Revision and further development of the supplier management processes within the QMS, taking into account relevant requirements for global medical device manufacturers (E.g. ISO 13485, EU MDR) as well as order to deliverer related processes.
• Development and implementation of suitable strategies for the optimization of risk-based internal & external outsourced processes
• Collaboration in interdisciplinary project teams to improve internal and external supplier performance. Moderation of continuous improvement workshops.
• Support Quality Awareness initiatives within the Warehousing & Distribution QMS for Hubs & Spokes. Capture best practices and actively share success within the community.
• Manage QA/RC projects & support supply chain improvement projects
• Facilitate and support internal and external audits

Requirements and Qualification :

• Bachelor’s or master’s degree in Business administration / QA / Life sciences or equivalent. Minimum of 5 years’ experience in establishing and maintaining regulated Quality Management Systems.
• Knowledge of regulatory requirements and international quality standards (MDR, ISO 13485, FDA 21 CFR 820)
• Excellent writing & communication skills in English, as well as interpersonal relationship skills including negotiating and relationship management.
• Experience in project management and leading process improvement methodologies
• Demonstrated experience in driving progress, taking initiative to achieve results.
• Extensive knowledge of site qualification, process validation and process release including the conducting of audits
Have sound knowledge of validation principles, problem-solving techniques and operational excellence.

This role could be based in Venlo, Netherlands or in Bensheim, Germany.

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!