Orascoptic Quality Engineer (On-Site Madison, WI)
Envista Holdings Corporation
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.
Job description
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.
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.
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.
- 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.
Benefits
- Annual performance bonus
- Medical, Dental & Vision
- 401(k) Matching
Company overview
Envista Holdings Corporation is a global leader in dental products and solutions, operating as a family of more than 30 trusted dental brands united by a shared purpose to partner with dental professionals to improve lives. Founded in 2018 as a spin-off from Danaher Corporation and going public in 2019, Envista has established itself as one of the largest global dental products companies with a comprehensive portfolio covering approximately 90% of dentists' clinical needs. The company's diversified offerings include dental implant systems, orthodontic solutions, diagnostic imaging technologies, and dental consumables, marketed under renowned brands such as Nobel Biocare, Ormco, DEXIS, Kerr, and Spark. With operations spanning over 130 countries and approximately 12,000 employees worldwide, Envista generated $2.5 billion in annual revenue in 2024. The company's products are found in an estimated 90% of dental clinics globally, supported by one of the industry's largest commercial organizations and distribution networks. Envista's business is organized into two main segments: Specialty Products & Technologies (including implant-based tooth replacements and orthodontic solutions) and Equipment & Consumables (covering diagnostic solutions and dental consumables). The company operates on the Envista Business System methodology, emphasizing continuous improvement, innovation, and customer-centricity to drive operational excellence and market leadership in the global dental industry.