Job Description
No Sponsorship or C2C
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Must be able to work on-site in Indianapolis, Indiana
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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.
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Responsibilities
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- 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.
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Qualifications
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- 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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