About the Role
This is a
Principal Quality Engineer opportunity with a globally renowned medical technology company. This is a hybrid role and required to be in the office on a 2-3 days per week basis.
Key Responsibilities :
- Serve as subject matter expert in quality engineering regarding advanced machining and single use devices.
- Provide value to continuous improvement activities in product and process quality, validation, defect analysis, CAPA, and internal audits.
- Provide internal expertise on sterilization matters, including release processes and oversight of sterilization supplier.
- Ensure compliance with FDA, ISO, and MDR regulations, supporting internal and external audits.
- Lead initiatives to improve quality systems, lean manufacturing, and Six Sigma activities.
- Analyze quality data, prepare inspection procedures, and review engineering changes.
- Supervise and mentor Quality Engineer.
- Indirectly supervise and manage technical support staff.
- Ensure environmental monitoring and product sterility requirements are met.
Qualifications
- Bachelor’s degree in engineering and 8+ years of experience in medical device manufacturing and quality assurance.
- Knowledge of sterilization, clean rooms, machining, and injection molding.
- Proficiency in statistics, SPC, and quality engineering tools.
- Strong communication, problem-solving, and organizational skills.
- Experience with SAP and Minitab preferred.
Equal Opportunity : Agile Search is committed to considering exceptional individuals from all walks of life, regardless of identification of race, religion, gender, national origin, age, disability, marital status, or veteran status.
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