New · posted Nov 4
Envista · Medical Devices
Quality Engineer
- Madison, WI
- On-site
- Full-time
- Senior & Principal
The role
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.
What you need
- Bachelor’s degree in Biomedical, Mechanical, Manufacturing, Industrial, Electrical, Chemical, Materials, or Systems Engineering, or a closely related engineering field.
- Typically 2–5 years of quality experience in a regulated industry, preferably in medical devices.
- Hands-on experience applying validation, design controls, risk management, investigations, CAPA, statistical methods, and quality system requirements in manufacturing.
- Quality Engineer certification or another relevant professional certification preferred.
Required Skills and Abilities
- Working knowledge of applicable medical device quality system requirements, ISO, 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, 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.
- Microsoft Office skills and the ability to quickly learn eQMS, ERP, and other business systems; experience with MasterControl, Oracle, or comparable systems preferred.
- Ability to manage multiple priorities with minimal oversight, adapt to changing business needs, communicate effectively in English, and travel as required.
What you'll do
- Develop and execute validation protocols (IQ, OQ, PQ) for equipment, processes, and systems, including software.
- Prepare comprehensive validation reports and analyze and interpret validation data to identify trends, anomalies, and areas for improvement.
- Ensure validation activities comply with regulatory requirements and organizational/industry standards.
- 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, 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.
Pay and benefits
$79,200 – $96,800 a year
Employer providedTarget 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.
For Field Sales roles, the salary range listed reflects base pay only and does not include incentive pay opportunities under the applicable sales compensation plan
$79,200 - $96,800
Annual performance bonus
Medical benefits
Dental benefits
Vision benefits
401K match
Where you'll work
Madison, WIOn-siteOpen in Maps (opens in a new tab)
More jobs in Madison, WIWorking conditions
- Employee 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.
IND123
Equal opportunity, accessibility and legal noticesEnvista's statements, word for word
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.
To 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.
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.
Job intelligence
The context around this role
Live data · November 4, 2026
Salary intelligence
How the pay compares
This role's midpoint is 29% below the US median for Quality Engineering roles at this level.
This roleEmployer provided
Senior & Principal roles in the US100 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $79,200 | — | $96,800 |
| All US (middle half) | $105,875 | $124,000 | $143,500 |
This role: Envista's own published range. Comparisons: the base pay employers published on open Quality Engineering roles at the same level on Regulatory Jobs, November 4, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Engineering
The general path across 211 open Quality Engineering roles on Regulatory Jobs, with the titles they carry most. Not Envista's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 23 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Quality systems and risk9
- Validation and qualification7
- GMP and compliance5
- Lab testing and methods5
- Documentation and SOPs5
- Collaboration and leadership5
- Investigations and CAPA2
- Data and digital systems2
- Clinical trial conduct1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Quality Engineering work in medical devices, led by the one this posting names, each linked to the agency or standards body that publishes it.
- FDA21 CFR Part 820 (QMSR)(official source, opens in a new tab)FDA quality management system regulation for medical devices, aligned with ISO 13485Named in the posting
- ISOISO 13485(official source, opens in a new tab)Quality management systems for medical devices
- ISOISO 14971(official source, opens in a new tab)Application of risk management to medical devices
- ISOISO 2859-1(official source, opens in a new tab)Sampling procedures for inspection by attributes (AQL sampling plans)
- FDA21 CFR Part 803(official source, opens in a new tab)Medical device reporting of deaths, serious injuries and malfunctions
- EUEU MDR (Regulation 2017/745)(official source, opens in a new tab)The EU Medical Device Regulation: CE marking, technical documentation, vigilance
- ISOISO 19011(official source, opens in a new tab)Guidelines for auditing management systems
- IECIEC 62366-1(official source, opens in a new tab)Application of usability engineering to medical devices
- ISOISO 10993-1(official source, opens in a new tab)Biological evaluation of medical devices within a risk management process
- ISOISO 11135(official source, opens in a new tab)Ethylene oxide sterilization of health care products
- ISOISO 11137-1(official source, opens in a new tab)Radiation sterilization of health care products
- ISOISO 11607-1(official source, opens in a new tab)Packaging for terminally sterilized medical devices
- ISOISO 11737-1(official source, opens in a new tab)Determination of the microbial population (bioburden) on medical devices
- FDAFDA Computer Software Assurance(official source, opens in a new tab)Risk-based assurance for production and quality system software
- FDA21 CFR Part 806(official source, opens in a new tab)Reports of medical device corrections and removals
- IECIEC 60601-1(official source, opens in a new tab)Basic safety and essential performance of medical electrical equipment
Company hiring pulse
Envista on Regulatory Jobs
- 12
- Open roles
- 11
- Distinct roles
- 7
- Locations
By discipline
- Quality6 50%
- Regulatory4 33%
- Clinical2 17%
By level
- Associate & Specialist5 42%
- Manager4 33%
- Senior & Principal2 17%
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Quality Engineer at Envista
Open until filled. $79K–$97K a year, employer provided.