Senior Quality Engineer
On-site · West Lafayette, Indiana, United States
Job Summary
Senior Quality Engineer to lead cross-functional quality initiatives for regenerative medicine manufacturing. Responsibilities include leading the Quality Assurance Engineering team, driving continuous improvement and KPIs, supporting regulatory submissions, guiding investigations and change management, and ensuring patient safety through robust quality programs. Must have expertise in validation, risk management, nonconformance investigations, and statistical methods; certifications such as ASQ CQE/CQA/CBA, Lead Auditor, or AATB/CTBS are valued.
Required Qualifications
- Experience leading nonconformance investigations and change management workflows
- Expertise with validation and risk management supporting regulatory submissions
- Knowledge of statistical techniques used in quality engineering
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