United States of America, New Jersey, Mahwah

R5026880

United States of America Engineering Job description The Junior Quality Engineer is responsible for the support of daily activities to maintain the quality management system, including supporting incoming inspection, calibration process, training, complaint handling, supplier quality, etc., and ensure quality standards, processes, and procedures are in compliance. The Junior Quality Engineer will also participate in cross-functional projects supporting quality and process improvement initiatives. The Junior Quality Engineer also helps to ensure Nobel Biocare's continued regulatory compliance in accordance with the

FDA CFR 820, ISO 13485

2016 and MDSAP (Medical Device Single Audit Program) and the Medical Device Regulations in the EU (MDR).

ACCOUNTABILITIES

- Ensure exceptional service for internal customers Follow all procedures (SOPs) and documentation related to the Quality Management System to ensure compliance to all standards Support the development, revision and maintenance of procedures, documentation and standards, relevant to the Quality Management System (Incoming inspection, training, calibration, etc.) that ensure best practices and compliance Assist in the resolution of quality issues related to non-conformance reports, cell shutdowns, customer complaints, process performance, product performance, etc. Support complaint investigations and documentation activities under the guidance of senior quality personnel, according to the medical device regulations;

FSA 21 CFR

Part 820 and

ISO 1348

2016, leading to process/product improvements Assist in implementing process improvements by using problem solving techniques, such as Problem-Solving Process (PSP), Variation Reduction (VRK) and continuous improvement techniques such as Value Stream Mapping (VSM), Transactional Process Improvement (TPI), and Lean/Six Sigma Assist in development, review and approval of process and equipment validation/qualifications (IQ, OQ, PQ) Lead and/or support CAPA investigations and related corrective and preventive actions Ensure training support and effectiveness for multiple functions throughout the organization Partner with functional teams to support maintenance of the QMS training program per regulatory requirements Assist in the reporting of effectiveness of the Quality Management System Provide support for internal and external audits and inspections Assist in ensuring department goals and objectives are reached Report the status of the Quality Management System and other related issues on a regular basis to the Sr. QA Engineer and/or Quality Assurance Manager Other duties as assigned by the Quality Assurance Manager Job requirements Bachelor's degree in Engineering or related field, or equivalent combined education and experience Minimum 1 year of experience as a Quality Engineer, or equivalent experience working with Quality Management Systems or with process/product improvements in a manufacturing environment Must reside withing a commutable distance to Mahwah, NJ. This is not a hybrid or remote role.

PREFERRED SKILLS

Prior work experience in a regulated medical device or pharmaceutical environment preferred Prior experience participating in regulatory audits a plus Prior experience managing complex data sets or statistical tools a plus Knowledge of quality systems and regulatory requirements applicable to medical devices (e.g., FDA

QMSR/QSR, ISO 13485, MDR

) preferred Ability to support investigations, CAPAs, nonconformances, complaints, and continuous improvement activities using structured problem-solving methodologies Strong analytical skills with the ability to review and interpret data, identify trends, and support data-driven decision making Proficiency in Microsoft Office applications; advanced Excel skills preferred Experience with ERP, quality management, or learning management systems preferred Ability to develop, review, and maintain quality documentation with a high level of accuracy and attention to detail Basic understanding of validation and qualification requirements for equipment, processes, and systems Strong communication and collaboration skills with the ability to work effectively in cross-functional teams Excellent organizational skills and ability to prioritize work in a fast-paced, regulated environment Demonstrated learning agility, initiative, and commitment to continuous improvement #

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. $62,200.00 - $105,800.00

Annual Operating Company:

Nobel Biocare 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 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: https://www.dol.gov/sites/dolgov/files/ofccp/regs/compliance/posters/pdf/eeopost.pdf Read more

Nobel Biocare Operating Company:

Nobel Biocare Location:

United States of America, New Jersey, Mahwah Date Posted:

July 19 , 2026

Req Number:

R5026880

Benefits Caring for our employees and their families Health & Wellbeing We offer comprehensive programs designed to support the health and wellbeing of our employees and their families. From medical coverage to wellness resources, we prioritize helping our people thrive both physically and mentally. Retirement & Financial Benefits We are committed to supporting our employees' financial wellbeing—today and in the future. Our competitive compensation and retirement or savings programs are designed to help employees build financial confidence at every stage of their careers. Life & Disability Insurance We provide benefits that help protect employees and their loved ones when it matters most. Depending on location, our life and disability programs offer valuable financial security and added peace of mind during unexpected life events. Paid Time Off We know that time away from work is essential for rest, balance, and personal priorities. Our paid time off, holidays, and leave programs are designed to give employees the flexibility to recharge and take care of what matters most. Learning & Career Development We believe in investing in our people. Through learning opportunities, development programs, and career growth pathways, we empower employees to build meaningful careers and continue growing with us. Our hiring process At Envista, we're committed to helping you feel confident and prepared every step of the way. Our interview guide will walk you through what to expect, how to showcase your strengths, and how you can make an impact by helping us champion dental professionals and improve lives. 1. Application Review After you apply, our team will review your experience and qualifications. If your background aligns with the role, a recruiter will reach out to discuss the opportunity and next steps. 2. Interviews You'll meet with members of the hiring team to learn more about the role and share your experience. Depending on the position, this may include multiple conversations focused on your skills, experience, and how you can make an impact. 3. Offer Decision If selected, you'll receive an offer outlining compensation, benefits, and other details. Our team will guide you through the process and answer any questions to help you make an informed decision. 4. Onboarding Once you join, we'll support your transition with onboarding resources and guidance to help you get started and feel connected from day one.