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.

　　Quality & Validation Engineer

　　Job Description:

　　MIS is seeking a highly motivated and detail-oriented Validation Engineer with a background in the medical device and pharmaceutical industry to join our Quality Assurance Team. As a Validation Engineer, you will play a crucial role in ensuring the quality and compliance of our products and processes. If you are passionate about quality assurance, possess excellent problem-solving skills, and have a strong background in establishing or reviewing testing\ verification protocols within the medical device and pharmaceutical sectors, we encourage you to apply.

　　Responsibilities:

　　Validation Planning:Develop and execute validation plans for new and existing products, processes, and equipment.

　　Collaborate with cross-functional teams to define validation requirements, acceptance criteria and timelines.

　　Documentation and Compliance:Create and maintain validation documentation, including protocols, reports, and standard operating procedures (SOPs) in adherence to QMS standards.

　　Ensure compliance with industry standards and regulations, such as ISO123485, 21CFR820, MDR/MDD, and others.

　　Execution of Validation Protocols:Perform and oversee the execution of validation protocols, including IQ/OQ/PQ, process validation, and cleaning validation, adhering to industry-specific guidelines.

　　Analyze and interpret validation data to make recommendations for process improvements.

　　Risk Assessment:Conduct risk assessments specific to the products and manufacturing processes to identify potential quality and compliance risks and develop mitigation strategies.

　　Cross-Functional Collaboration:Collaborate with R&D, Engineering, Manufacturing, and other teams to integrate validation activities into the product development life cycle, considering industry-specific requirements.

　　Provide guidance on validation-related issues and ensure alignment with quality objectives.

　　Continuous Improvement:Participate in continuous improvement initiatives to enhance the efficiency and effectiveness of validation processes.

　　Qualifications:

　　Bachelor's degree in Engineering, Science, or related field.

　　Experience in validation processes- Advantage

　　Familiarity with QMS standards and regulations, including ISO123485, 21CFR820, MDR/MDD, etc.

　　Strong knowledge of validation principles, processes, and regulatory requirements within the medical device and pharmaceutical sectors.

　　Experience with risk assessment methodologies.

　　Excellent communication and interpersonal skills.

　　Ability to work independently and collaboratively in a team environment.

　　Detail-oriented with strong analytical and problem-solving abilities.

　　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.

　　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 [email protected] ([email protected]) . Please be sure to include “Accommodation Request” in the subject.