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 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

Job Requirements:

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 fulltime 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

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Target Market Salary Range:

Actual compensation packages take into account a wide range of factors that are unique to each candidate, including but not limited to geographic location; skill sets; relevant education and certifications; depth of experience; performance; and other business and organizational needs. The disclosed reasonable estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Envista, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. The total compensation package for this position may also include an annual performance bonus, medical/dental/vision benefits, 401K match, and/or other applicable compensation plans.

$80,300 - $95,000

Operating Company:

Nobel Biocare

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. The "EEO is the Law" poster is available at: http://www.dol.gov/ofccp/regs/ compliance/posters/pdf/eeopost.pdf.

Envista and its family of companies (Envista) will not accept unsolicited resumes from any source other than directly from a candidate. Envista will consider unsolicited referrals and/or resumes submitted by vendors such as search firms, staffing agencies, professional recruiters, fee-based referral services and recruiting agencies (Agency) to have been referred by the Agency free of charge and Envista will not pay a fee for any placement resulting from the receipt such unsolicited resumes. An Agency must obtain advance written approval from Envista's internal Talent Acquisition or Human Resources team to submit resumes, and then only in conjunction with a valid fully-executed contract approved by the Global Talent Acquisition leader and in response to a specific job opening. Envista will not pay a fee to any Agency that does not have such agreement and written approval in place.