Senior Quality Validation Engineer – Medical Devices

Nemera; Buffalo Grove (IL); On-site; USD 85,000 - 105,000; Full time

Job summary

Nemera is seeking a Quality Validation Engineer - Equipment Validation to plan and manage validations ensuring our devices meet customer and regulatory requirements. You will coordinate investigations, write protocols, and work with suppliers to uphold quality.

The role demands 3+ years in quality, ISO13485 familiarity, and hands-on experience with IQ/OQ/PQ in a manufacturing environment, with strong communication in English and the ability to travel up to 25%.

Qualifications

• Bachelor’s degree in Engineering, Science or related field.
• 3+ years of experience in a Quality position.
• Experience in Medical Device industry (ISO13485).
• Experience with equipment validation (IQ/OQ/PQ).
• Experience working onsite in manufacturing.
• Excellent written and spoken English.

Responsibilities

• Coordinate and manage validations and write protocols.
• Lead investigations of customer complaints and CAPA activities.
• Coordinate supplier quality evaluations and audits.
• Support ISO and FDA QSR quality systems compliance.
• Identify process improvements using Six Sigma tools.

Skills

Quality engineering

Statistical analysis

Project coordination

Independent work

Education

Bachelor’s degree in Engineering or Science

Tools

SAP

MS Office

IQ/OQ/PQ documentation

Job description

Nemera is seeking a Quality Validation Engineer - Equipment Validation to plan and manage validations ensuring our devices meet customer and regulatory requirements. You will coordinate investigations, write protocols, and work with suppliers to uphold quality.

The role demands 3+ years in quality, ISO13485 familiarity, and hands-on experience with IQ/OQ/PQ in a manufacturing environment, with strong communication in English and the ability to travel up to 25%.