Job Description

Role: Quality Engineer – Medical Devices

Duration: 6-12+ Months

Location: Buffalo Grove, IL

What You’ll Do

• Lead and manage Quality Assurance (QA) systems, including CAPA, audits, and compliance.
• Ensure all products, processes, and records meet FDA, ISO 13485, and internal standards.
• Collaborate cross-functionally to resolve quality issues and improve systems.
• Analyze QA data, track trends, and report key metrics regularly.
• Develop and deliver training on quality systems and best practices.
• Serve as a lead representative during internal/external audits.
• Investigate non-conformances and drive corrective actions.
• Mentor and guide other QA team members.
• Support global initiatives and maintain effective communication across teams.

What We’re Looking For

• Bachelor’s degree in Engineering or a related technical field (advanced degree a plus).
• 1-5+ years of QA or engineering experience in a regulated industry (medical device preferred).
• Strong knowledge of FDA regulations, GMP, and ISO 13485.
• Proven leadership in QA systems and cross-functional project teams.
• Skilled in data analysis, reporting, and quality metrics.
• Excellent communication and problem-solving skills.
• Experience with CAPA management, audits, and risk assessments.
• Certifications like ASQ CQE/CQA/CQT and Six Sigma preferred.

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