Design Quality Engineer - Richardson, TX

Design Quality Engineer - Richardson, TX

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.

Bringing out the best in people

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.

We are looking for an experienced and talented Design Quality Engineer who will be responsible for design quality ownership of products (medical device and software) within the Orthodontics Aligner Solutions group of Dentsply Sirona and to be the quality representative at the Richardson TX site.

The ideal candidate will be a hands‑on team player, willing to learn from others, who has experience with software (testing, quality assurance, test documentation and tools) and device (DMR, DHF, testing, and quality assurance) requirements in the medical device industry. This position works closely with the Dentsply Sirona’s software development team and device R&D teams, as well as with internal cross‑functional departments to ensure regulatory compliance is maintained with both medical device files and improvement/change initiatives.

This position works in an Agile environment with little supervision. The candidate must demonstrate the ability to assume responsibilities beyond the traditional scope of DQE role, including leading external audits, defining and reporting program metrics, driving QMS improvements, and supporting CAPA activities.

This job will require up to 10% of travel inside and occasionally outside US, and usually less than one week at a time. A valid passport is required.

• Evaluates software processes and software products to assess conformity with applicable standards, models, and defined software engineering program requirements.
• Ensures quality is embedded within program processes and deliverables by evaluating completeness, consistency, correctness, and conformance to requirements.
• Performs quality assessments throughout the full software and/or medical device development lifecycle, including post‑market and maintenance activities.
• Determines whether program objectives and quality standards have been met and identifies opportunities for continued improvement.
• Tracks and manages nonconformances, software defects, trend analysis, root cause analysis, and corrective and preventive action activities for the program
• Acts as the Business Unit Quality lead for New Product Development and Design Change Management
• Complies with company and departmental policies and administrative requirements
• Reviews software defects by fully understanding and risk assessing prior to approving or recommending alternate mitigations.
• Manages escalation of complex and high priority issues
• Estimates time needed for project QA tasks, accurately accounting for complexity and effort level
• Stays current with…