Orascoptic Quality Engineer (On-Site Madison, WI)

Envista; Madison (WI); On-site; USD 73,000 - 89,000; Full time

Benefits offered by this job

Health & Wellbeing

Retirement & Financial Benefits

Life & Disability Insurance

Paid Time Off

Learning & Career Development

Job summary

Envista is seeking a Quality Engineer to independently lead validation activities across new product development, sustaining engineering, and manufacturing. You will serve as the Quality representative on cross-functional teams, applying design controls, risk management, and statistical methods to ensure product and process quality.

The role requires onsite presence in Madison, WI, with 2–5 years of quality experience in a regulated environment.

Qualifications

• Bachelor's degree in a related engineering discipline and 2–5 years quality experience in a regulated industry.
• Experience with validation, design controls, risk management, investigations, CAPA, statistics, and quality systems in manufacturing.
• Familiarity with FDA QSR/ISO 13485, GMP, and regulatory expectations; strong writing skills.

Responsibilities

• Lead validation activities for processes, equipment, software and test methods from planning to final reporting.
• Serve as Quality representative for NPD, sustaining engineering, verification/validation, risk management, and design/process changes.
• Lead investigations for nonconformances, CAPAs, supplier or manufacturing quality issues with root cause analysis and corrective actions.

Skills

Quality engineering

Validation

Design controls

Risk management

Statistical methods

FMEA

CAPA

Root cause analysis

Quality systems

Regulatory knowledge

Education

Bachelor's degree in Biomedical/Mechanical/Manufacturing/Industrial/Electrical/Chemical/Materials/Systems Engineering

Tools

MasterControl

Oracle

MS Office

Job description

United States of America, Wisconsin, MadisonR5027329United States of AmericaQuality and Regulatory AffairsJob descriptionJOB SUMMARY:The Quality Engineer independently leads technical quality engineering and validation activities supporting new product development, sustaining engineering, manufacturing, and quality system compliance. The role serves as a Quality representative on cross-functional teams and applies validation, design controls, risk management, statistical methods, and structured problem-solving to ensure products and processes meet applicable regulatory, quality system, and customer requirements.Candidate must reside within a commutable distance to Madison, WI This is not a hybrid or remote opportunity and requires onsite presence 5 days per week.PRIMARY DUTIES & RESPONSIBILITIES:Lead process, equipment, software, and test method validation activities, including planning, protocol development, execution oversight, data analysis, deviation resolution, final reporting, and maintenance of applicable validation master plans.Serve as the Quality Engineering representative for new product development, sustaining engineering, verification and validation, risk management, and design or process changes, including review and approval of applicable technical documentation.Lead or provide technical support for investigations involving nonconformances, complaints, CAPAs, and supplier or manufacturing quality issues, including root cause analysis, corrective action development, and effectiveness assessment.Apply quality engineering and statistical tools, including DOE, Gauge R&R, SPC, FMEA, capability analysis, sampling plans, and trend analysis, to assess risk and improve products, processes, inspection methods, and control strategies.Lead technical supplier quality support for qualification, audits, validations, change assessments, and evaluation of supplier corrective action responses, while routine SCAR administration and supplier monitoring remain within Quality Systems.Participate in regulatory, notified body, customer, corporate, and internal audits by providing technical documentation and evidence-based responses within the role’s areas of responsibility.Partner with R&D, Manufacturing Engineering, Operations, Regulatory, Procurement, and Quality Systems to ensure quality requirements are appropriately incorporated and maintained throughout the product lifecycle.Provide technical guidance to less experienced Quality Associates and support assigned departmental quality and continuous improvement initiatives.Follow departmental Standard Operating Procedures, Work Instructions, and applicable safety requirements.Incidental Duties: The above statements describe the general nature and level of work being performed. They are not intended to be an exhaustive list of all duties. Additional responsibilities may be assigned by management, as required.Job requirementsQualificationsTo perform this job successfully, an individual must be able to perform each essential duty satisfactorily and function effectively in a fast-paced environment where priorities may change. The requirements below are representative of the knowledge, skill, and ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.REQUIREMENTS:Bachelor’s degree in Biomedical, Mechanical, Manufacturing, Industrial, Electrical, Chemical, Materials, or Systems Engineering, or a closely related engineering discipline.2-5 years of quality experience in a regulated industry.Practical experience with validation, design controls, risk management, investigations, CAPA, statistical methods, and quality system requirements in a manufacturing environment.Working knowledge of applicable FDA medical device quality system requirements, ISO 13485, GMP requirements, and relevant international standards.Ability to independently interpret and apply regulatory, quality system, technical, and customer requirements and resolve complex quality issues using structured problem-solving.Proficiency in statistical analysis and data interpretation, including practical applications of DOE, Gauge R&R, SPC, FMEA, capability analysis, and sampling methods.Strong technical writing, project leadership, organization, and cross-functional communication skills.Ability to understand product applications, specifications, functionality, assembly, manufacturing processes, and test methods.Ability to manage multiple priorities with minimal oversight, adapt to changing business needs, communicate effectively in English, and travel as required.PREFERRED QUALIFICATIONS:Quality Engineer certification or other relevant professional certification is preferred.Medical device industry experience is preferred.Advanced proficiency with Microsoft Office and the ability to learn electronic quality management, ERP, and other business systems; experience with MasterControl, Oracle, or similar systems is preferred.Physical DemandsEmployee is required to sit at a desk for extended periods and frequently use hands and fingers.Position requires occasional standing, walking, reaching, bending, and stooping.The work environment has a moderate noise level. Safety glasses are required in production areas or as otherwise indicated.#LI-SC1IND123Target 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.$73,100 - $89,400Operating Company:Nobel BiocareEnvista 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.pdfRead moreNobel BiocareOperating Company:Nobel BiocareLocation:United States of America, Wisconsin, MadisonDate Posted:September 16 , 2026Req Number:R5027329BenefitsCaring for our employees and their familiesHealth & WellbeingWe 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 BenefitsWe 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 InsuranceWe 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 OffWe 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 DevelopmentWe 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 processAt 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 ReviewAfter 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. InterviewsYou’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 DecisionIf 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. OnboardingOnce you join, we’ll support your transition with onboarding resources and guidance to help you get started and feel connected from day one.