Orascoptic Quality Engineer

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

Job summary

Orascoptic is seeking a Quality Engineer to independently lead validation activities for new product development and sustaining engineering. You will represent Quality on cross-functional teams, apply design controls, risk management, and statistical methods to ensure compliance with regulatory and customer requirements.

The role requires onsite presence in Madison, WI, with 5 days per week in the facility and experience in manufacturing quality systems.

Qualifications

• Bachelor’s degree in Biomedical, Mechanical, Manufacturing, Industrial, Electrical, Chemical, Materials, or Systems Engineering or a closely related discipline.
• 2–5 years of quality experience in a regulated industry.
• Hands-on experience with validation, design controls, risk management, CAPA, and statistical methods.

Responsibilities

• Lead validation activities for processes, equipment, software and test methods from planning to reporting.
• Act as Quality Engineering representative for new product development, sustaining engineering, verification/validation, risk management, and changes.
• Lead investigations of nonconformances, CAPAs, supplier quality issues with root cause analysis and corrective actions.
• Apply DOE, Gauge R&R, SPC, FMEA, capability analysis, sampling plans and trend analysis to improve products and processes.
• Provide technical guidance and support for supplier qualification, audits, validations, and SCAR monitoring within Quality Systems.
• Support regulatory audits with technical documentation and evidence-based responses.
• Collaborate with R&D, Manufacturing, Operations, Regulatory, Procurement and Quality Systems to maintain quality throughout product lifecycle.

Skills

Statistical methods

Design controls

Risk management

Validation

Quality systems

Project leadership

Cross-functional communication

Education

Engineering degree

Tools

MasterControl

Oracle

ERP systems

Microsoft Office

Job description

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.

Job Requirements:

Qualifications

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.

#LI-SC1
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.

$73,100 - $89,400

Operating Company:

Orascoptic

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.