Onsite Medical Device Quality Engineer - Validation & Risk

Nobel Biocare; Madison (WI); On-site; USD 73,000 - 89,000; Full time

Job summary

Nobel Biocare is seeking a Quality Engineer to independently lead quality engineering and validation activities across new product development, sustaining engineering, manufacturing, and quality systems. The role requires onsite presence near Madison, WI and serves as the Quality representative on cross-functional teams to ensure products meet regulatory and customer requirements.

You will apply validation, design controls, risk management, statistical methods, and structured problem-solving to

Qualifications

• Bachelor’s degree in an engineering discipline.
• 2–5 years of quality experience in a regulated industry.
• Experience with validation, design controls, risk management, investigations, CAPA, statistical methods, and quality system requirements.

Responsibilities

• Lead validation activities for processes, equipment, software, and test methods.
• Support new product development, sustaining engineering, and quality systems with QA input.
• Lead investigations for nonconformances, CAPAs, and supplier/manufacturing quality issues with root-cause analysis and corrective actions.
• Apply DOE, Gauge R&R, SPC, FMEA, capability analysis, sampling plans, and trend analysis to improve products and processes.
• Provide technical support for audits and supplier quality activities within Quality Systems.

Skills

Quality engineering

Validation

Statistical methods

Design controls

Risk management

CAPA investigations

DOE

Gauge R&R

SPC

FMEA

Data analysis

Cross-functional collaboration

Education

Bachelor’s degree in Biomedical/Mechanical/Manufacturing/Industrial/Electrical/Chemical/Materials or Systems Engineering

Tools

MasterControl

Oracle

Microsoft Office

Job description

Nobel Biocare is seeking a Quality Engineer to independently lead quality engineering and validation activities across new product development, sustaining engineering, manufacturing, and quality systems. The role requires onsite presence near Madison, WI and serves as the Quality representative on cross-functional teams to ensure products meet regulatory and customer requirements.

You will apply validation, design controls, risk management, statistical methods, and structured problem-solving to