Quality Engineer

No Sponsorship or C2C

Must be able to work on-site in Indianapolis, Indiana

This candidate will be responsible for the development, implementation, maintenance, and continuous improvement of quality assurance processes within a medical device manufacturing environment. The ideal candidate will have experience working in a regulated medical device industry and familiarity with ISO 13485 and quality management systems .

Responsibilities

• Perform problem identification, root cause analysis, CAPA, loss reporting, and continuous improvement activities.
• Develop and implement methods for process control, process improvement, testing, and inspection.
• Develop, execute, and analyze quality metrics and reporting measures.
• Participate in internal and external quality audits.
• Support nonconformance investigations and quality improvement initiatives.
• Collaborate with Engineering, Manufacturing, and Operations to improve product and process quality.

Qualifications

• Bachelor's degree or equivalent in Mechanical, Electrical, Manufacturing, Biomedical Engineering, or a related field.
• 2–3+ years of industry experience, preferably in medical device manufacturing.
• Experience with ISO 13485 and Quality Management Systems (QMS) .
• Strong knowledge of quality tools, root cause analysis, and continuous improvement.
• Analytical and quantitative approach to problem solving.
• Strong communication and cross-functional collaboration skills.