Quality Engineer

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, problemsolving, 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, timemanagement, and organizational abilities Positive, energetic approach to teamwork and crossfunctional collaboration Demonstrated ability to advocate for product excellence and quality with empathy and professionalism Resultsoriented mindset with the ability to multitask and learn quickly Proficiency with datadriven tools to analyze and interpret large, complex datasets Track record of driving measurable improvements in yield, reliability, or process robustness Handson 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 #LI-CY1 IND123 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: 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. Envista is a global family of more than 30 trusted dental brands, united by a shared purpose: to partner with professionals to improve lives. Envista helps its customers deliver the best possible patient care through industry-leading dental consumables, solutions, technology, and services. Our comprehensive portfolio, including dental implants and treatment options, orthodontics, and digital imaging technologies, covers an estimated 90% of dentists' clinical needs for diagnosing, treating, and preventing dental conditions as well as improving the aesthetics of the human smile. Envista companies, including DEXIS, Kerr, Nobel Biocare and Ormco, partner with dental professionals to help them deliver the best possible patient care. Envista became an independent company in 2019. We brought with us the proven Envista Business System (EBS) methodology, an experienced leadership team, and a strong culture grounded in continuous improvement, commitment to innovation, and deep customer focus to meet the end-to-end needs of dental professionals worldwide. Envista is now one of the largest global dental products companies, with significant market positions in some of the most attractive segments of the dental products industry. For more information, please visit www.envistaco.com.