Design Quality Engineer - Richardson, TX

Job Summary:

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

Job Responsibilities:

• • • 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 technology and changing trends, and provide recommendations for continuous improvement
    • Ensures all initiatives are compliant with regulatory and legal standards and company policies
    • Complies with company and departmental policies and administrative requirements.
    • Performs other duties as assigned or as needed

Education:

• • • Bachelor’s degree in a scientific discipline, or a related discipline

Years and Type of Experience:

• Minimum of 5 years’ experience in Design Quality and Software Quality within Medical Device, Pharma, BioMed or other regulated industry
• Experience in FDA Good Manufacturing Practices and/or ISO Quality Management System Requirements
• Quality Manager Certification and/or Certified Quality System Auditor is a plus
• Cybersecurity experience preferred

Key Skills, Knowledge & Capabilities:

• Proficient computer skills, Microsoft Office Suite (Word, PowerPoint, Outlook, and Excel), and instructional software
• Microsoft Dynamics AX and TrackWise knowledge preferred
• Strong validation knowledge and background
• Excellent organizational skills and the ability to manage multiple priorities
•  Ability to fill all aspects of the Quality function, including Quality Engineering, QMS, New Product Development, Design Changes.
• Ability to present software quality assessment of products and processes to the Global Business Unit, and on occasion to Senior Leadership