Quality Engineer, Medical Devices – Validation & Compliance

Envista Holdings Corporation; Alabama; On-site; USD 73,000 - 89,000; Full time

Job summary

Envista Holdings Corporation seeks an experienced Quality Engineer to independently lead validation activities for new product development, sustaining engineering, and manufacturing. You will act as the Quality representative on cross-functional teams, applying validation, design controls, risk management, and statistical methods to ensure regulatory and customer requirements are met.

This role requires onsite presence in Madison, WI, five days a week.

Qualifications

• Bachelor’s degree in Biomedical, Mechanical, Manufacturing, Industrial, Electrical, Chemical, Materials, or Systems Engineering.
• 2-5 years of quality experience in a regulated industry.
• Experience with validation, design controls, risk management, investigations, CAPA, statistical methods, and QA system requirements.
• Working knowledge of FDA medical device quality system requirements, ISO 13485, GMP, and international standards.
• Proficiency in statistical analysis including DOE, Gauge R&R, SPC, FMEA, sampling methods.
• Strong technical writing, project leadership, organization, and cross-functional communication.

Responsibilities

• Lead validation for processes, equipment, software and test methods; plan, execute, report, maintain validation master plans.
• Serve as Quality Eng representative for NPD, sustaining, verification/validation, risk management, design/process changes.
• Lead investigations for nonconformances, CAPAs, supplier or manufacturing quality issues; perform root cause analysis.
• Apply DOE, Gauge R&R, SPC, FMEA, capability analysis, sampling plans, trend analysis to improve quality.
• Provide supplier quality support for qualification, audits, validations, change assessments, and SCAR monitoring.
• Support audits with technical documentation and evidence-based responses.

Skills

Validation

Quality engineering

DOE

Gage R&R

SPC

FMEA

CAPA

Statistical methods

Education

Bachelor’s degree in Biomedical Engineering (or related engineering)

Tools

MasterControl

Oracle

Job description

Envista Holdings Corporation seeks an experienced Quality Engineer to independently lead validation activities for new product development, sustaining engineering, and manufacturing. You will act as the Quality representative on cross-functional teams, applying validation, design controls, risk management, and statistical methods to ensure regulatory and customer requirements are met.

This role requires onsite presence in Madison, WI, five days a week.