Medical Device Quality Validation Engineer

Nemera; 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 customer and internal quality deliverables. You will lead investigations of customer complaints, work with Supply Chain to evaluate supplier performance, and collaborate with teams on validations, change controls, and CAPA activities.

Qualifications include a Bachelor’s in Engineering/Science, 3+ years in quality, ISO13485 experience, and strong English communication.

Qualifications

• Bachelor’s degree in Engineering, Science or related field.
• 3+ years' experience in a Quality position preferred.
• Medical Device industry experience preferred (ISO13485).
• Experience with technical writing; IQ/OQ/PQ is preferred.

Responsibilities

• Assist Quality Manager to coordinate objectives across departments to maximize quality and efficiency.
• Identify and resolve system inefficiencies that increase quality costs.
• Coordinate and manage validation activities and written protocols.
• Coordinate change control activities and supplier quality evaluations.
• Support customer audits and ensure FDA QSR and ISO compliance.

Skills

Quality engineering

Statistical analysis

CAPA problem solving

Technical writing

English communication

Education

Bachelor’s degree in Engineering/Science or related field

Tools

IQ/OQ/PQ

Six Sigma

SAP

Job description

Nemera is seeking a Quality Validation Engineer to plan, coordinate and manage projects ensuring products meet customer and internal quality deliverables. You will lead investigations of customer complaints, work with Supply Chain to evaluate supplier performance, and collaborate with teams on validations, change controls, and CAPA activities.

Qualifications include a Bachelor’s in Engineering/Science, 3+ years in quality, ISO13485 experience, and strong English communication.