Dentsply Sirona · 3 days ago
Quality Engineer
Lancaster, PA
Full-time
Onsite
Mid, Senior Level
3+ years expDentsply Sirona is the world’s largest manufacturer of professional dental products and technologies, dedicated to improving dental care. The QA Engineer plays a critical role in ensuring the effectiveness and compliance of the Quality Management System, focusing on quality excellence across distribution operations and supporting regulatory requirements.
DentalEducationHealth CareManufacturingMedical Device
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
Qualification
Required
3 to 5+ years of experience in Quality Assurance, ideally within a regulated environment
Prior experience in the medical device and/or pharmaceutical industry required
Company
Dentsply Sirona
Dentsply Sirona is a manufacturer of dental products and technologies.
10001+ employees
H1B Sponsorship
Dentsply Sirona has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (28)
2024 (14)
2023 (7)
2022 (14)
2021 (9)
2020 (16)
Funding
Current Stage
Public CompanyTotal Funding
$550M2025-06-05Post Ipo Debt· $550M
1987-08-21IPO
Leadership Team
Daniel Scavilla
President and Chief Executive Officer
Matthew Garth
Chief Financial Officer
Recent News
2025-11-25
Company data provided by crunchbase