Process/Quality Engineering

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

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