The Quality Assurance Specialist supports and coordinates the QMS activities for Harmony Distribution Order to Delivery process Optimization projects (Distribution integration, new sites, returns and process optimization). It is a role whereby your skills and competencies will be optimized in order to work on daily tasks and activities related to Quality Assurance as well as being part in one of the biggest transformation projects Dentsply Sirona has known in its history.

This role ensures a standardized and structured approach to Dentsply Sirona Distribution and QARC processes which will make sure that all external and internal Stakeholders are aware and acting according to their roles and responsibilities.

Quality Assurance Specialist, Venlo - Netherlands
(Temporary contract of at least 12 months)

Responsibilities:

• Assist with implementing and maintaining a Distribution Quality Management System (QMS) strategy at sites connected to the Distributor network.

• Define action plans to implement improvements and coordinate with suppliers the follow-up of projects and quality initiatives to achieve the quality requirements and the stability of the processes

• Evaluate supplier quality performance metrics and initiate investigations into trends or repetitive events as required

• Report information to appropriate areas of the business e.g., Purchasing, Operations and Suppliers

• Lead the implementation of quality related Change Control activities

• Improvement and maintenance of the key figure system

• Work with sites to implement Quality processes and corrective action plans when resolving issues

• Revision and further development of the processes within our QMS, considering relevant requirements for global medical device manufacturers (E.g., ISO 13485, EU MDR) as well as order to deliver related processes

• Development and implementation of strategies for the optimization of risk-based internal & external outsourced processes

• Collaboration in interdisciplinary project teams to improve internal and external supplier performance. Lead and manage continuous improvement workshops

• Support Quality Awareness initiatives within the Harmonized QMS structure for Distributors
  

Requirements and Qualifications:

• Minimum Bachelor’s degree in engineering or equivalent

• Several years’ experience in establishing and maintaining regulated Quality Management Systems (ideally within the medical device industry), including, and not limited to change management and change control.

• Proven experience in project management and leading process improvement methodologies (Lean Six Sigma, DMAIC)

• Experience in Data Management and Document Management obtained during project related tasks

• Knowledge of Sharepoint and Power BI is a plus

• Demonstrated experience 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

• Knowledge of regulatory requirements & international quality standards (E.g., MDR, ISO 13485, FDA 21 CFR 820, MDR)

• Fluent in English verbally as well as in writing is required, any other language is a plus

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!