Impactful Quality Engineer - Process Improvement

CAIRE Inc.; Canton (GA); On-site; USD 70,000 - 110,000; Full time

Job summary

CAIRE Inc. seeks a Quality Engineer to provide day-to-day quality engineering support for manufacturing operations and product lines, ensuring compliance with specifications and regulatory standards. You will lead investigations, CAPAs, MSA, and participate in process improvements across the product lifecycle.

You will collaborate with Manufacturing, Engineering, Regulatory Affairs, and Quality teams to reduce variation, maintain QA systems, and support audits and supplier quality initiatives.

Qualifications

• Master's or BS with regulated industry experience; reading engineering drawings.
• Proficient in Microsoft Office (Excel, Word, PowerPoint).
• Excellent written and verbal communication across levels.
• Experience with ISO 13485, FDA QMS, ISO 14971 preferred.
• Knowledge of quality tools and data analysis.

Responsibilities

• Provide day-to-day quality engineering support for assigned manufacturing operations and product lines.
• Lead or participate in cross-functional product and process improvement teams.
• Lead root cause investigations, develop corrective actions, and drive continuous product improvements across the product lifecycle.
• Ensure internal adherence to established SOPs and document control practices.

Skills

Reading engineering drawings

Statistical analysis

Problem-solving

Communication skills

Team orientation

Education

Master's in Engineering

BS degree in Engineering + 2 years regulated experience

10+ years of relevant experience

Tools

Minitab

Tableau

Excel

Job description

CAIRE Inc. seeks a Quality Engineer to provide day-to-day quality engineering support for manufacturing operations and product lines, ensuring compliance with specifications and regulatory standards. You will lead investigations, CAPAs, MSA, and participate in process improvements across the product lifecycle.

You will collaborate with Manufacturing, Engineering, Regulatory Affairs, and Quality teams to reduce variation, maintain QA systems, and support audits and supplier quality initiatives.