QA Engineer

QA Engineer

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.

As advanced as dentistry is today, we are dedicated to making it even better. Our people have a passion for innovation and are committed to applying it to improve dental care. We live and breathe high performance, working as one global team, bringing out the best in each other for the benefit of dental patients, and the professionals who serve them. If you want to grow and develop as a part of a team that is shaping an industry, then we're looking for the best to join us.

Working at Dentsply Sirona you are able to:

• Develop faster - with our commitment to the best professional development.
• Perform better - as part of a high-performance, empowering culture.
• Shape an industry - with a market leader that continues to drive innovation.
• Make a difference -by helping improve oral health worldwide.

The QA Engineer plays a critical role in ensuring the effectiveness, compliance, and continuous improvement of the Quality Management System (QMS) within the Lancaster Distribution Center and the broader North American distribution network. This position is responsible for developing, implementing, and maintaining robust quality system processes, including supplier controls, internal audits, and supporting external audits conducted by regulatory agencies. The QA Engineer serves as a key driver of quality excellence across distribution operations, ensuring alignment with regulatory requirements, corporate standards, and customer expectations.

Key Responsibilities:

• Maintain systems, processes, and documentation to support compliance with FDA, ISO 13485, and other applicable international quality standards.
• Lead quality-related activities for standard and specialized distribution processes, including country-specific labeling, supplemental labeling, and other market-specific requirements.
• Ensure proactive and effective fulfillment of distributor, repackager, relabeler, and initial importer regulatory requirements across the Lancaster Distribution Center and the North American distribution network.
• Manage the quality intake and evaluation of new activity requests to ensure alignment with regulatory and internal quality standards.
• Lead and coordinate Nonconformances (NCs), Corrective and Preventive Actions (CAPAs), and Change Control processes to ensure timely resolution of issues and controlled implementation of changes.
• Establish, monitor, analyze, and report on key performance indicators (KPIs) and quality metrics to identify trends, drive continuous improvement, and support strategic decision-making.
• Collaborate with internal stakeholders to ensure readiness for inspections and audits related to distribution, repackaging, relabeling, and importing activities.
• Monitor regulatory and industry changes, assess their impact on distribution processes, and ensure timely updates to procedures and internal controls.
• Support the development and implementation of quality strategies that enhance compliance and reduce risk across the supply chain.
• Act as a liaison between the distribution center and regulatory, commercial, and supply chain partners to ensure alignment and transparency regarding quality requirements and expectations.
• Partner with Operations and Supply Chain teams to troubleshoot and resolve system-specific quality issues.

Experience & Qualifications:

• 3 to 5+ years of experience in Quality Assurance, ideally within a regulated environment.
• Prior experience in the medical device and/or pharmaceutical industry strongly preferred.

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 careers@dentsply.com. Please be sure to include "Accommodation Request" in the subject.

Nearest Major Market: Lancaster