Orascoptic Quality Engineer (On-Site Madison, WI)

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.

• ◆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

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

may be assigned by management, as required.

Job

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

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.

• ✓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

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

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.