Quality Validation Engineer - FDA/ISO Compliance & CAPA

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

Job summary

Nemera is seeking a Quality Validation Engineer to plan, coordinate, and manage projects ensuring products meet quality deliverables. You will lead investigations into customer complaints and work with Supply Chain to evaluate supplier performance.

Strong emphasis on ISO, FDA QSR, and Six Sigma methods across production environments. The role requires onsite work in a manufacturing setting with occasional travel.

Qualifications

• Bachelor’s degree in Engineering, Science or related field.
• 3+ years in a Quality position, preferred.
• Experience in Medical Device industry (ISO13485) preferred.
• Experience with IQ/OQ/PQ and validation activities preferred.
• Proficient in Excel and data analysis techniques.

Responsibilities

• Coordinate and manage validations and written protocols.
• Lead investigations of customer complaints and CAPA activities.
• Assess conformance to FDA QSR, ISO and customer requirements.
• Develop product specifications and validate supplier quality evaluations.
• Support quality agreements with suppliers and internal teams.

Skills

Communication skills

Statistical knowledge (SPC)

Independent work

English proficiency

Six Sigma

Education

Bachelor’s degree in Engineering, Science or related field

Tools

SAP

Microsoft Office

Job description

Nemera is seeking a Quality Validation Engineer to plan, coordinate, and manage projects ensuring products meet quality deliverables. You will lead investigations into customer complaints and work with Supply Chain to evaluate supplier performance.

Strong emphasis on ISO, FDA QSR, and Six Sigma methods across production environments. The role requires onsite work in a manufacturing setting with occasional travel.