Quality Engineer

Envista Holdings Corporation•Mahwah, NJ

7d•Onsite

About The Position

PURPOSE – The Quality Engineer ensures quality standards, processes and procedures are in compliance to specific requirements for the Nobel Biocare Quality Management System. The Quality Engineer also manages projects directly with cross-functional teams to ensure fulfillment of all necessary FDA and ISO 13845 requirements and ensures compliance to the appropriate quality system regulations and procedures. ACCOUNTABILITIES – Develop, implement and maintain the Quality Assurance Management System, including SOPs, in accordance with ISO 13485 and other applicable quality system requirements Identify and drive implementation of continuous improvement opportunities across processes, production, QA testing, and systems. Assist in the development, review and approval of process and equipment validation/qualifications (IQ, OQ, PQ) Lead the resolution of quality issues related to non-conformance reports, cell shutdowns, customer complaints, process performance, etc. Actively oversee production and quality control activities in the manufacturing areas to ensure compliance via random internal audits or checks Lead and/or support CAPA investigations and related corrective and preventative actions Lead Gauge R&R studies and measurement system analysis to ensure measurement accuracy and reliability. Translate Risk Management meetings and insights into actionable process risk controls across production lines. Perform advanced data analysis to identify trends, detect anomalies, and support predictive quality. Support supplier qualification, audits, and ongoing supplier quality management, ensuring robust quality throughout the supply chain. Drive structured problem-solving initiatives for both internal and supplier-related issues Collaborate across Process Developement, Process Engineering, and Production to drive solutions Provide support for internal and external audits and inspections Suggest corrective actions to improve the Quality System and operations Guide all functions towards decided quality objectives Other duties as assigned by the Quality Assurance Manager

Requirements

Bachelor's of Science in an engineering, technical or quality discipline, or equivalent degree required
Minimum three (3) years of experience in engineering, product development, or medical device testing, validation, or verification, or equivalent required
Ability to travel domestically or internationally as needed
Must reside within a commutable distance to Mahwah, NJ.
This is a fulltime onsite position and not hybrid or remote.

Nice To Haves

Working knowledge of CNC milling or other precision manufacturing processes, preferred
Experience in dental lab operations, prosthetic workflows, or dental product fabrication is a plus
Foundational understanding of manufacturing processes; experience with glass, ceramics, zirconia, or other advanced materials strongly preferred
Strong computer literacy, including proficiency with Microsoft Office Suite
Ability to effectively work cross-functionally with other departments including Operations, Process Engineering, Product Development, and Distribution
Demonstrated analytical, problem‑solving, and troubleshooting skills, with a structured approach (e.g., 5 Whys, Fishbone, DMAIC)
Strong interpersonal and communication skills; professionalism in all internal and external interactions
Excellent planning, time‑management, and organizational abilities
Positive, energetic approach to teamwork and cross‑functional collaboration
Demonstrated ability to advocate for product excellence and quality with empathy and professionalism
Results‑oriented mindset with the ability to multi‑task and learn quickly
Proficiency with data‑driven tools to analyze and interpret large, complex datasets
Track record of driving measurable improvements in yield, reliability, or process robustness
Hands‑on mindset with routine presence at the gemba to identify, investigate, and resolve quality issues
Flexibility to work in a dynamic environment and willingness to travel domestically or internationally as needed
Working knowledge of Minitab statistical software preferred

Responsibilities

Develop, implement and maintain the Quality Assurance Management System, including SOPs, in accordance with ISO 13485 and other applicable quality system requirements
Identify and drive implementation of continuous improvement opportunities across processes, production, QA testing, and systems.
Assist in the development, review and approval of process and equipment validation/qualifications (IQ, OQ, PQ)
Lead the resolution of quality issues related to non-conformance reports, cell shutdowns, customer complaints, process performance, etc.
Actively oversee production and quality control activities in the manufacturing areas to ensure compliance via random internal audits or checks
Lead and/or support CAPA investigations and related corrective and preventative actions
Lead Gauge R&R studies and measurement system analysis to ensure measurement accuracy and reliability.
Translate Risk Management meetings and insights into actionable process risk controls across production lines.
Perform advanced data analysis to identify trends, detect anomalies, and support predictive quality.
Support supplier qualification, audits, and ongoing supplier quality management, ensuring robust quality throughout the supply chain.
Drive structured problem-solving initiatives for both internal and supplier-related issues
Collaborate across Process Developement, Process Engineering, and Production to drive solutions
Provide support for internal and external audits and inspections
Suggest corrective actions to improve the Quality System and operations
Guide all functions towards decided quality objectives
Other duties as assigned by the Quality Assurance Manager