Quality Engineer - Medical Devices (ISO 13485, FDA)

Del Medical; Bloomingdale (IL); On-site; USD 50,000 - 60,000; Full time

Benefits offered by this job

Paid time off

Holidays off

Health insurance

Dental insurance

Vision insurance

401(k) plan

Disability & Life insurance

Professional development

Collaborative work environment

Job summary

Del Medical in Bloomingdale, IL is seeking an Entry Level Quality Engineer to join our QA team. You will help maintain robust processes to ensure regulatory compliance and product quality across medical imaging devices.

Responsibilities include audits, CAPA, data analysis, quality metrics, and collaboration with engineering and manufacturing to embed quality across production. This role offers growth in medical device design and manufacturing with a supportive, experienced team.

Qualifications

• Bachelor’s degree or diploma in Science, Engineering, Quality or similar discipline.
• 2 years of experience in Engineering, Manufacturing Engineering or similar in a regulated environment preferred.
• Strong attention to detail and ability to manage quality documents.
• Strong analytical and problem-solving skills.
• Excellent written and verbal communication skills.
• Proficiency in Microsoft Office (Word, Excel, PowerPoint).
• Ability to work in a fast-paced environment and collaborate with cross-functional teams.

Responsibilities

• Lead internal and external audits to comply with ISO 13485, MDSAP, and FDA regulations.
• Support the CAPA process by identifying root causes and implementing corrective measures.
• Partner with cross-functional teams to implement process improvements and boost product quality.
• Continuously identify and lead initiatives to enhance quality, efficiency, and reliability.
• Analyze quality data, track trends, and present opportunities for process improvements.
• Prepare quality reports and present findings to management for informed decision-making.
• Monitor and help achieve quality performance indicators (KPIs).
• Participate in lean manufacturing projects to reduce waste and boost production efficiency.
• Innovate and propose improvements to quality systems and processes.
• Manage supplier corrective actions and maintain detailed supplier quality records.
• Train team members on quality standards and best practices, ensuring a strong culture of quality across departments.
• Collaborate with other departments to embed quality assurance in every aspect of production.
• Maintain regulatory submissions, compliance files, and product labeling to ensure alignment with ISO 13485, Part 820, and MDSAP.
• Support the management of the Quality Management System (QMS) and ensure it remains audit ready.
• Work with engineering and manufacturing teams to implement regulatory requirements during product development and production.
• Support design reviews, risk assessments, and validation/verification activities.
• Stay up-to-date with regulatory changes and provide insights on emerging trends in medical device regulations.
• Assist in ensuring product compliance through post-market surveillance and vigilance reporting.

Skills

Attention to detail

Analytical and problem-solving

Written and verbal communication

Cross-functional collaboration

Education

Bachelor’s degree in Science/Engineering/Quality

Tools

Microsoft Office

Job description

Del Medical in Bloomingdale, IL is seeking an Entry Level Quality Engineer to join our QA team. You will help maintain robust processes to ensure regulatory compliance and product quality across medical imaging devices.

Responsibilities include audits, CAPA, data analysis, quality metrics, and collaboration with engineering and manufacturing to embed quality across production. This role offers growth in medical device design and manufacturing with a supportive, experienced team.