Onsite Quality Engineer - Medical Device Validation Lead

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

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.