Quality Engineer - Medical Device Validation & Compliance

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

Job summary

Envista’s Orascoptic is seeking a Quality Engineer who leads validation activities across new product development, sustaining engineering, and manufacturing to ensure compliance with FDA QSR, ISO 13485, and GMP. The role serves as the quality representative on cross-functional teams and uses structured problem solving and statistical methods to guarantee product quality.

The successful candidate must reside within commuting distance to Madison, WI.

Qualifications

• Bachelor's degree in engineering or closely related field.
• 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 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.

Responsibilities

• Lead validation activities for processes, equipment, software, and test methods.
• Serve as the Quality Engineering representative for new product development, sustaining engineering, verification and validation, risk management, and design or process changes.
• Lead or provide technical support for investigations involving nonconformances, complaints, CAPAs, and supplier or manufacturing quality issues.
• Apply quality engineering and statistical tools 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.
• Participate in regulatory, notified body, customer, corporate, and internal audits by providing technical documentation and evidence-based responses.
• Partner with R&D, Manufacturing Engineering, Operations, Regulatory, Procurement, and Quality Systems to ensure quality requirements are incorporated throughout the product lifecycle.
• Provide technical guidance to less experienced Quality Associates and support departmental quality and continuous improvement initiatives.
• Follow departmental SOPs, Work Instructions, and applicable safety requirements.

Skills

Validation

Quality engineering

Regulatory compliance

Statistical analysis

Risk management

DOE/Gauge R&R/SPC/FMEA

Education

Bachelor's degree in engineering

Job description

Envista’s Orascoptic is seeking a Quality Engineer who leads validation activities across new product development, sustaining engineering, and manufacturing to ensure compliance with FDA QSR, ISO 13485, and GMP. The role serves as the quality representative on cross-functional teams and uses structured problem solving and statistical methods to guarantee product quality.

The successful candidate must reside within commuting distance to Madison, WI.