Orascoptic Quality Engineer (On-Site Madison, WI)

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

Job summary

Envista in Madison, WI is seeking a Quality Engineer to lead validation, risk management, and quality systems across NPD, sustaining engineering, and manufacturing. You will serve on cross-functional teams, applying DOE, Gauge R&R, SPC, FMEA, and sampling plans to ensure product and process compliance.

The role requires onsite presence five days a week, with strong collaboration across R&D, Regulatory, and Operations to drive continuous improvement and regulatory compliance.

Qualifications

• Bachelor's degree in an engineering discipline related to medical devices or manufacturing.
• 2–5 years of quality experience in a regulated industry.
• Experience with validation, design controls, risk management, CAPA, statistics, and quality systems.
• Knowledge of FDA QSR, ISO 13485, GMP, and international standards.

Responsibilities

• Lead validation activities for processes, equipment, software, and test methods with reports and SPD alignment.
• Represent Quality in R&D, manufacturing, and regulatory activities; review documentation.
• Lead investigations of nonconformances, CAPAs, and supplier quality issues with root cause analysis.
• Apply DOE, Gauge R&R, SPC, FMEA, capability analysis, sampling, and trend analysis to improve products.
• Provide supplier quality support for qualification, audits, validations, and corrective actions.
• Support audits with technical documentation and evidence-based responses.
• Collaborate with R&D, Manufacturing, Regulatory, Procurement, and Quality Systems to embed quality across the lifecycle.
• Mentor junior Quality Associates and support continuous improvement initiatives.
• Follow SOPs, work instructions, and safety requirements.

Skills

Quality engineering

Statistical methods

Regulatory knowledge

Cross-functional teamwork

Education

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

Tools

MasterControl

Oracle

Job description

Job 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.

Qualifications

Job requirements:

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.

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 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.

IND123

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 - $89,400

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