Senior Quality Assurance Manager

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 solution 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.

For over 25 years, MIS, now a member of Dentsply Sirona group, has been developing and producing advanced products and innovative solutions, aimed to simplify implant dentistry. Through state-of-the-art production facilities, MIS offers a comprehensive range of high-quality dental implants, superstructures, tools and kits, regenerative solutions, and digital dentistry services.

MIS is Hiring a Senior Quality Assurance Manager

Position Summary:

The position is responsible for the continuous development and enhancement of the Quality Management System (QMS) to ensure the Implant Business remains compliant with current standards and regulations; oversees and manages the Quality Assurance and Quality Control teams, ensuring they operate efficiently and effectively

Additionally, this position ensures that Product Development Projects and other improvement initiatives are properly implemented across the organization, and provides Quality Assurance guidance to the Manufacturing Team, ensuring that all processes meet the required quality standards.

Key Responsibilities

• Leads, coordinates, and plans the work within the QA and QC.
• Coaches and leads the dedicated QA Team to develop adequate competencies, efficient working methods, optimal use of resources and a stimulating working climate.
• Secures representation of SQE/QE in Product Development Project and other Projects to secure compliance with requirements.
• Maintains and continuously improves procedures and instructions related to area of responsibility, compliant to ISO 13485:2016, FDA 21 CFR 820, 2017/745 MDR, and applicable regulatory requirements where the Product is marketing while complying with corporate requirements.
• Acts as Process Owner for CAPA and Nonconformity Process; secures the process is implemented and followed within the organization.
• Acts as Process Owner for Document Control.
• Manages QA activities within Supplier Control such as QA Agreements, Approved Supplier List, Re-evaluation of Suppliers and Supplier Audits. Partner with Global and Local Purchasing.
• Fosters a philosophy of continuous improvement in the organization.
• Oversees the Process Validation and close co-operation with the Manufacturing Team.
• Oversees External Audits at the Site, secure planning, execution and follow up are performed according to timelines and requests from External Authorities.
• Oversees the management of the cost center(s) for the dedicated Team.
• Manages the PMS Process including Complaint Handling, Post Marketing Surveillance activities. Mandate to block Products due to Quality issue and ultimate responsible for Market Actions.
• Performs Quality Review of documents related to the QMS.
• Takes an active part in the Change Control Process as QA representative; Member of the Change Board.
• Takes an active part in Design Transfer activities such as Purchase Approval and Production Start Process.

Requirements, Skills, And Capabilities

• Requires an academic background with knowledge in relevant subject and more than five years’ experience from working with Quality Assurance/Control from the medical device industry.
• Skilled knowledge of US FDA 21 CFR Part 820 – Quality System Regulation
• Skilled knowledge ISO 13485:2016 Medical Devices – Quality Management Systems
• EU’s Regulation (EU) 2017/745 on medical devices, also known as EU Medical Device Regulation
• Good knowledge and experience from Notified Body Audits and FDA Inspections.
• At least 3 years of full manager responsibility, including personnel and budget responsibility.
• Previous experience working with Implants is beneficial.
• A careful, responsible, and structured way of working.
• Good communication, writing and interpersonal skills with the ability to manage multiple projects and work independently.
• Full command of the English language, both written and spoken.

Step into a role where your expertise will drive excellence and innovation at the forefront of dental implant technology.🗣️🧩

For additional details and questions, contact us at [email protected]