Quality Engineer - Medical Devices (Onsite in Madison)

Envista Holdings Corporation; Madison, Northern (WI, KY); Hybrid; USD 73,000 - 89,000; Full time

Job summary

Orascoptic is seeking a Quality Engineer to independently lead quality engineering and validation activities across new product development and manufacturing. This role requires on-site presence in Madison, WI, and collaboration with cross-functional teams to ensure regulatory and customer requirements are met.

The ideal candidate has 2–5 years in a regulated manufacturing environment, strong expertise in validation, design controls, risk management and statistical methods, and a proactive

Qualifications

• Bachelor's degree in an engineering discipline (biomedical, mechanical, manufacturing, etc.).
• 2-5 years quality experience in a regulated industry.
• Experience with validation, design controls, risk management and CAPA in manufacturing.

Responsibilities

• Lead validation activities for processes, equipment, software and test methods.
• Act as Quality representative for NPD, sustaining engineering, verification/validation and changes.
• Lead investigations of nonconformances, CAPAs, supplier or manufacturing quality issues.
• Participate in audits and support cross-functional teams to ensure compliance.

Skills

Validation

Design controls

Risk management

Statistical methods

DOE

Gauge R&R

SPC

CAPA

Regulatory knowledge

Education

Biomedical, Mechanical, Manufacturing, Industrial, Electrical, Chemical, Materials, or Systems Engineering

Tools

MasterControl

Oracle

Microsoft Office

Job description

Orascoptic is seeking a Quality Engineer to independently lead quality engineering and validation activities across new product development and manufacturing. This role requires on-site presence in Madison, WI, and collaboration with cross-functional teams to ensure regulatory and customer requirements are met.

The ideal candidate has 2–5 years in a regulated manufacturing environment, strong expertise in validation, design controls, risk management and statistical methods, and a proactive