Senior Quality Assurance Specialist - Venlo, Netherlands

Requistion ID: 76305 

Senior Quality Assurance Specialist

Scope of the role:

The Senior Quality Assurance Specialist coordinates the process for managing, securing, reporting and utilizing distribution related QARC data to support Dentsply Sirona Order to Delivery processes, within the centralized Importer & Distributor Quality Management System (QMS). This to ensure data quality, compliance with regulations and alignment with business objectives.

The role acts independently as a liaison for Dentsply Sirona Distributors & Distribution Centers in change processes related to QMS, Value Added Services and Continuous Improvement. This will be done in such a way that the organization continues to meet regulatory, 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.

Your 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)
• Support the implementation and maintenance of the harmonized Dentsply Sirona Global Distribution Quality Management System (QMS) strategy at sites and entities connected to the global Hub & Spoke Distributor network.
• Coordinate with suppliers the follow-up of projects and quality initiatives to achieve the quality requirements and process stability. Based on the results, define action plans to implement necessary improvements.
• Evaluate supplier quality performance metrics and initiate investigations into trends or recurring events as needed. Report information to appropriate business units (i.e., purchasing and operations) and 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.
• Review and improvement of 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 supplier 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. Facilitate continuous improvement workshops.
• Support Quality Awareness initiatives within the DS Distribution Network sites & entities. 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 Education:

• Bachelor’s degree in engineering or equivalent (Business administration / QA / Life sciences or equivalent
• 3-5+ years’ experience in establishing and maintaining regulated Quality Management Systems
• Knowledge of regulatory requirements & 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
• Knowledge and experience with data analytics and tools like PowerBi.

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!