Quality Engineer - Medical Devices & QMS Innovator

Del Medical Inc; Bloomingdale (IL); On-site; USD 70,000 - 100,000; Full time

Benefits offered by this job

Competitive salary

PTO and holidays

Health, dental, vision insurance

401(k) retirement plan

STD, LTD, Life and AD&D

Professional development

Job summary

Del Medical Inc. is seeking a Quality Engineer to uphold high product quality and regulatory compliance across medical imaging solutions. You will support the Quality Assurance team, maintain robust QMS processes, and drive continuous improvement in design and manufacturing.

The role involves audits, CAPA, supplier quality records, and post-market vigilance to ensure alignment with ISO 13485, 820, and MDSAP. Join a team focused on safety, reliability, and regulatory excellence.

Qualifications

• Bachelor's degree in Science, Engineering, Quality or related field required.
• Strong analytical and problem-solving skills with attention to detail.
• Excellent written and verbal communication skills; ability to document and report clearly.

Responsibilities

• Lead internal and external audits to ensure ISO 13485, MDSAP and FDA compliance.
• Support CAPA process by identifying root causes and implementing corrective actions.
• Collaborate with cross-functional teams to drive process improvements and product quality.

Skills

Attention to detail

Analytical thinking

Communication

Team collaboration

Education

Bachelor's degree in Science/Engineering/Quality

Tools

Microsoft Office

Job description

Del Medical Inc. is seeking a Quality Engineer to uphold high product quality and regulatory compliance across medical imaging solutions. You will support the Quality Assurance team, maintain robust QMS processes, and drive continuous improvement in design and manufacturing.

The role involves audits, CAPA, supplier quality records, and post-market vigilance to ensure alignment with ISO 13485, 820, and MDSAP. Join a team focused on safety, reliability, and regulatory excellence.