Quality Engineer: Validation, Risk & Improvement

Nobel Biocare; Madison (WI); On-site; USD 79,000 - 97,000; Full time

Job summary

Nobel Biocare in Madison, WI, seeks a Quality Engineer to independently lead validation and quality activities across new product development, sustaining engineering, and manufacturing. You will apply design controls, risk management, and statistical methods to ensure compliance with regulatory and customer requirements.

Ideal candidates have 2–5 years of quality experience in regulated environments and familiarity with ISO/GMP standards.

Qualifications

• Bachelor’s degree in Biomedical, Mechanical, Manufacturing, Industrial, Electrical, Chemical, Materials, or Systems Engineering, or a closely related engineering field.
• Typically 2–5 years of quality experience in a regulated industry, preferably in medical devices.
• Hands-on experience applying validation, design controls, risk management, investigations, CAPA, statistical methods, and quality system requirements in manufacturing.
• Quality Engineer certification or another relevant professional certification preferred.

Responsibilities

• Develop and execute validation protocols (IQ, OQ, PQ) for equipment, processes, and systems, including software.
• Prepare comprehensive validation reports and analyze and interpret validation data to identify trends, anomalies, and areas for improvement.
• Ensure validation activities comply with regulatory requirements and organizational/industry standards.
• Serve as the Quality Engineering representative for new product development, sustaining engineering, verification and validation, risk management, and design or process changes, including review and approval of applicable technical documentation.
• Lead or provide technical support for investigations involving nonconformances, complaints, CAPAs, and supplier or manufacturing quality issues, including root cause analysis, corrective action development, and effectiveness assessment.
• Apply quality engineering and statistical tools, including DOE, FMEA, capability analysis, sampling plans, and trend analysis, 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, while routine SCAR administration and supplier monitoring remain within Quality Systems.
• Participate in regulatory, notified body, customer, corporate, and internal audits by providing technical documentation and evidence-based responses within the role’s areas of responsibility.
• Partner with R&D, Manufacturing Engineering, Operations, Regulatory, Procurement, and Quality Systems to ensure quality requirements are appropriately incorporated and maintained throughout the product lifecycle.
• Provide technical guidance to less experienced Quality Associates and support assigned departmental quality and continuous improvement initiatives.
• Follow departmental Standard Operating Procedures, Work Instructions, and applicable safety requirements.

Skills

Quality systems

Statistical analysis

Problem solving

Cross-functional communication

English proficiency

Project leadership

Technical writing

Manufacturing processes

Education

Bachelor's in Engineering

Tools

MasterControl

Oracle

ERP systems

Job description

Nobel Biocare in Madison, WI, seeks a Quality Engineer to independently lead validation and quality activities across new product development, sustaining engineering, and manufacturing. You will apply design controls, risk management, and statistical methods to ensure compliance with regulatory and customer requirements.

Ideal candidates have 2–5 years of quality experience in regulated environments and familiarity with ISO/GMP standards.