Quality Engineer

Job Description 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 Development, 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 Qualifications 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 full‑time onsite position and not hybrid or remote. Preferred Skills 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 Target Market Salary Range $80,300 - $95,000 Operating Company Nobel Biocare IND123 Envista and all Envista Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. 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