Quality Engineer
meet life sciencesIndianapolis (IN)
About the role
No Sponsorship or C2CMust 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.
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