Quality Engineer, Medical Devices — CAPA & Process Excellence

Lumitex; Brecksville (OH); On-site; USD 60,000 - 80,000; Full time

Job summary

A medical device company based in Brecksville, Ohio is seeking a Quality Engineer to enhance product quality through rigorous testing and problem-solving. This role involves working with design quality, leading non-conformance investigations, and supporting quality assurance programs. Ideal candidates will have a bachelor’s degree in engineering and 1-5 years of relevant experience, preferably in the medical device field. Attention to detail and strong problem-solving skills are essential for this position.

Qualifications

• Bachelor’s degree in engineering, science, or equivalent.
• 1-5 years quality assurance experience, with Medical Device experience strongly preferred.

Responsibilities

• Participate in design quality activities and ensure product specifications.
• Lead and support non-conformance report investigations.
• Support the Customer Return Authorization process to reduce customer complaints.
• Conduct internal audits for quality management system compliance.
• Develop and maintain quality assurance programs and policies.

Skills

Strong problem-solving skills

Attention to detail

Develop standardized component test methods

Create Process Risk Analysis Documentation

Self-motivated

Education

Bachelor’s degree in engineering

1-5 years quality assurance experience

Job description

A medical device company based in Brecksville, Ohio is seeking a Quality Engineer to enhance product quality through rigorous testing and problem-solving. This role involves working with design quality, leading non-conformance investigations, and supporting quality assurance programs. Ideal candidates will have a bachelor’s degree in engineering and 1-5 years of relevant experience, preferably in the medical device field. Attention to detail and strong problem-solving skills are essential for this position.