Quality Engineer - Med Devices & Regulatory Compliance

Katalyst CRO; Buffalo Grove (IL); On-site; USD 85,000 - 120,000; Full time

Job summary

Katalyst CRO is seeking a Quality Assurance professional to support remediation efforts across product lines, ensuring compliance with design control, CAPA, and risk management. The role encompasses developing and maintaining DMRs, product specifications, and CE technical files.

Responsibilities include leading supplier quality programs, conducting investigations, and coordinating cross-functional QA activities to uphold quality standards. Travel up to 15% is required.

Qualifications

• Ability to work with limited supervision and escalate when needed.
• Strong problem-solving and analytical skills.
• Experience with quality systems and document control.

Responsibilities

• Provide quality expertise in product development, design control, CAPA, risk management, and CE technical files.
• Lead supplier quality activities and coordinate supplier qualifications and CAPA implementations.
• Investigate non-conformances and implement corrective actions to minimize defects.

Skills

Time management

Problem solving

Independent work

Attention to detail

Tools

MS Office

Microsoft Excel

Job description

Katalyst CRO is seeking a Quality Assurance professional to support remediation efforts across product lines, ensuring compliance with design control, CAPA, and risk management. The role encompasses developing and maintaining DMRs, product specifications, and CE technical files.

Responsibilities include leading supplier quality programs, conducting investigations, and coordinating cross-functional QA activities to uphold quality standards. Travel up to 15% is required.