QA Engineer
Company: Dentsply Sirona
Location: Bausman
Posted on: December 31, 2025
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Job Description:
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. Job
Description: QA Engineer 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.
Keywords: Dentsply Sirona, Philadelphia , QA Engineer, Science, Research & Development , Bausman, Pennsylvania