Quality Engineer - York, PA

Scope
Under general supervision, this position is responsible for site complaint handling for Imaging Devices, including all aspects for reportability in various regions. Participates in the various Quality Engineering efforts which include but are not limited to new product development, benchmarking, process improvement implementation, nonconformances, corrective and preventive actions, process and design validation, key supplier quality initiatives, test method and gage design and control, and root-cause analysis of defects from manufacturing and customer returns. 

Essential Functions
Quality Engineer 

•  Assure all Sensor (Imaging Devices) medical device complaints are triaged and managed within the electronic system (completed by evaluating contract manufacturer investigations in concert with other colleagues as needed). 
• Develop and implement methods and procedures to continuously monitor customer satisfaction concerning product returns, performance, and quality to assist top management in problem resolution and product decision making.
•  Identify quality issues; develop, implement, and perform trend analysis on corrective and preventive actions through coordinated efforts with internal and external stakeholders as required.
• Coordinate problem or root-cause investigations for acute defect problems.
•  Review, document, log, maintain and/or initiate the investigation for potentially serious complaints.
• Continuously improve techniques for functional and extended performance testing.
• Develop, implement, and control quality programs for the conformance of product systems, including such information as the number of units to be inspected/tested, testing frequency, test methods and yield determination.
• Assist with calibration and control of gages as required.
• Identify areas for improvement and lead the effort for continuous process improvement.
• Work with cross-functional teams to improve material flow, ensure process quality, reduce work in process, and achieve required capacity/cycle time requirements to meet or exceed customer requirements.
• Control non-conforming product and is responsible for its disposition.
• Support Corrective and Preventive Action (CAPA) Teams.
• Support Product Surveillance Committee (PSC) and CAPA Oversight Committee (COC) activities.
•  All other duties as assigned.

Typical Background
Education:  

• High school diploma or GED required.
• Bachelor’s Degree in Quality Assurance, Science, Engineering or related field preferred.  

Certifications/Licensing:

• Professional certification in Quality Assurance or Six Sigma preferred but not required.

Years and Type of Experience:

• 3 to 5 year’s experience in quality engineering in a regulated manufacturing environment preferred.  

Key Required Skills, Knowledge and Capabilities:

• Good understanding of cGMP, ISO 9000/9001/13485 and FDA Quality Systems.
• Strong computer skills with knowledge of Microsoft Office Suite (Word, Excel, Access and PowerPoint), e-mail and Internet.  Experience with quality-specific systems like SmartSolve, LMS, ClearTrack, Tarius, Accolade, BPCS and/or TrackWise a plus.
• Excellent communication skills – written and verbal.
• Interpersonal skills to include customer-focused orientation with both internal and external customers.
• Strong decision-making skills, ability to work independently with minimal supervision.
• Comprehensive organization and analytical skills.
• Business acumen to effectively analyze trends and data.

Key Behaviors Critical for Success in this Role:
Here at Dentsply Sirona, our vision is to transform dentistry to improve oral health globally.

Every day, we empower millions of customers by proudly creating innovative solutions for healthy smiles.

Our Operating Principles guide our daily activities:

• We approach customers as ONE company, and they are the core of everything we do.
• We create innovative solutions that customers love to use.
• We think and act with positive intent and the highest integrity.
• We operate sustainably in everything we do.
• We use our size and global breadth to our advantage.

Our Core Values define who we are:

• AGILE:
  • We innovate
  • We challenge ourselves constantly
  • We act quickly
• ACCOUNTABLE:
  • We hold ourselves and each other accountable.
• RESPECTFUL:
  • We listen.  We foster diversity and inclusion.
  • We respect the communities in which we live and work.
• COLLABORATIVE:
  • We are good partners.
  • We learn from each other.  We are one team.  We have fun.
• TRUSTWORTHY:
  • Our customers can rely on us.
  • We can rely on each other.  We empower our people.