Quality Engineer I

Essential Duties and Responsibilities

• Participate in product design and process development projects to ensure design controls and manufacturing processes meet quality and regulatory requirements.
• Develop, execute, and document process validations, method validations, and related qualification activities.
• Assist in the design and development of manufacturing processes, inspection methods, measurement systems, and testing tools.
• Support supplier quality initiatives by collaborating with suppliers and Supplier Quality Engineers to improve quality performance and assist with supplier qualification and validation activities.
• Participate in investigations related to customer complaints, corrective and preventive actions (CAPA), nonconformance reports (NCRs), and other quality events.
• Conduct root cause analyses and support implementation of effective corrective actions.
• Assist with internal and external audits as requested by Quality Engineering leadership.
• Partner with Engineering and Manufacturing teams to develop data-driven process controls and identify critical process variables for continuous improvement initiatives.
• Analyze quality and manufacturing data using statistical methods and present findings through technical reports and presentations.
• Support risk management activities and assist senior Quality Engineers with process development and quality improvement projects.
• Complete ongoing technical and quality system training to maintain compliance and professional development.
• Assist in establishing, tracking, and reporting quality metrics and objectives across the organization.
• Support compliance with applicable regulatory and quality system requirements.

Required Knowledge and Skills

• Knowledge of quality systems and regulatory requirements, including:
  • cGMP
  • 21 CFR Parts 210, 211, and 820
  • ISO 13485
  • ISO 14971
  • MDD, MDR, and MDSAP
• Understanding of quality system development, documentation, implementation, and maintenance.
• Basic knowledge of manufacturing statistics and quality engineering tools, including:
  • Statistical Process Control (SPC)
  • Control Charts
  • Root Cause Analysis
  • Design of Experiments (DOE)
  • Gauge R&R
• Proficiency with Microsoft Office applications.
• Familiarity with Oracle, Agile, Adobe, and Minitab or similar systems.
• Working knowledge of, or willingness to learn, one or more programming languages such as Python, R, SQL, or C++.
• Strong analytical and problem-solving skills.
• Excellent organizational, project management, and time management abilities.
• Ability to work independently while managing multiple priorities.
• Strong written and verbal communication skills, including technical writing and presentation skills.
• Ability to adapt quickly in a dynamic and collaborative environment.

Education and Experience

• Bachelor's degree in Engineering, Data Science, Physical Sciences, Life Sciences, or a related technical field from an accredited university.
• Academic or professional experience involving technical writing, statistical analysis, and presentation of technical data.

Preferred Technical Disciplines

• Physics
• Electronics
• Measurement Sciences
• Physical Chemistry
• Analytical Chemistry
• Chemical Engineering
• Electrical Engineering
• Mechanical Engineering
• Data Science

What You'll Bring

• A passion for quality and continuous improvement.
• Curiosity and a data-driven mindset.
• The ability to collaborate effectively across multiple departments.
• A proactive approach to problem-solving and process improvements

Ultradent is an Equal Opportunity Employer. We are a global culture where differences and perspectives are sought after, welcomed, and embraced. We consider all qualified applicants fairly, based on their experience, skills, and potential to contribute to our team. Our core values – Integrity, care, quality, innovation, and hard work- guide us daily. These values, when balanced, shape our workplace culture and ensure that we remain focused on our vision while maintaining a professional and inclusive environment.
  
VEVRAA Federal Contractor: For more information please contact us at Recruiting@ultradent.com

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