Envista

Envista

Orascoptic Quality Engineer (On-Site Madison, WI)

United States of America, Wisconsin, Madison · Mid

Sponsorship not specified$73k-$89kDetected 30 days ago
Data AnalysisStatisticsProduct ManagementProcurementERPRecruitingHRCustomer SupportSystems EngineeringGMPFDA RegulatoryMedical DevicesLeadershipCommunicationProblem SolvingWritingMicrosoft Office

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odds of building a lasting career here

37Risky
Cap-exempt (no lottery)0
Sponsors this role80
Entry-level history0
PERM / green-card track0
Lottery odds (Level I)39
Fits your clock70

Thin sponsorship signal and lottery-bound (~15% per draw). A low-probability bet with your clock running. Prioritize cap-exempt roles and proven entry-level sponsors first.

Lottery odds assume a STEM candidate.

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About the role

  • 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.
  • 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.
  • 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.

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.
  • 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.
  • Provide technical guidance to less experienced Quality Associates and support assigned departmental quality and continuous improvement initiatives.
  • 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.

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.
  • 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.
  • 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.
  • 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.
  • Additional responsibilities may be assigned by management, as required.
  • Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

Nice to have

  • Quality Engineer certification or other relevant professional certification 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 Demands
  • 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.

Compensation

  • 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.
  • 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 - $89,400

Benefits

  • 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.

Company info

  • 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.
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This listing is sourced directly from Envista's careers page and normalized into a canonical job model.