Quality Engineer: Med Devices, CAPA & Compliance

Katalyst CRO; Chicago (IL); On-site; USD 70,000 - 90,000; Full time

Job summary

Katalyst CRO seeks a Quality Engineer based in Chicago, IL, to establish quality standards across medical devices, OTC drugs, and cosmetics. This role involves evaluating production processes, managing suppliers, investigating non-conformities, and ensuring compliance with regulations. Qualified candidates should have at least 2 years of experience in Quality or Engineering, strong analytical skills, and proficiency in MS Office Suite. Experience in the medical device industry is preferred, and the position may offer hybrid work options.

Qualifications

• Proven experience in quality engineering and compliance.
• Ability to manage multiple projects and priorities effectively.
• Familiarity with regulatory requirements like 21 CFR 820 and ISO 13485.

Responsibilities

• Establish and maintain quality standards across products.
• Collaborate with suppliers to resolve quality issues.
• Evaluate production processes and recommend improvements.
• Conduct investigations on non-conformances and product testing.
• Create and manage product documentation related to quality control.

Skills

Problem-solving

Analytical skills

Knowledge of quality standards

Microsoft Excel proficiency

Education

Minimum 2 years of experience in Quality or Engineering

At least 2 years of industry experience in Medical Devices or Pharmaceuticals

Tools

MS Office Suite

Job description

Katalyst CRO seeks a Quality Engineer based in Chicago, IL, to establish quality standards across medical devices, OTC drugs, and cosmetics. This role involves evaluating production processes, managing suppliers, investigating non-conformities, and ensuring compliance with regulations. Qualified candidates should have at least 2 years of experience in Quality or Engineering, strong analytical skills, and proficiency in MS Office Suite. Experience in the medical device industry is preferred, and the position may offer hybrid work options.