Senior Quality Assurance Engineer
2 weeks ago
We are seeking a highly skilled and experienced Quality Assurance Engineer to join our team at KARL STORZ ENDOSCOPY. As a Quality Assurance Engineer, you will be responsible for ensuring the quality and safety of our medical devices, including sterilization processes and cleanroom environments.
Key Responsibilities- Provide sterilization expertise and oversee sterilization release processes.
- Support continuous improvement in product and process quality, including validation, defect analysis, CAPA, and internal audits.
- Ensure compliance with FDA, ISO, and MDR regulations, supporting both 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 technicians and provide training to QA and manufacturing teams.
- Ensure environmental monitoring and product sterility requirements are met.
- Bachelor's degree in engineering and 5+ 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 MS Office, SAP, and quality tools like Six Sigma and Minitab preferred.
KARL STORZ ENDOSCOPY is an independent, family-owned company headquartered in Germany's renowned MedTech manufacturing region. For 80 years, we've pioneered the most groundbreaking innovations in endoscopic surgery, video imaging, and OR integration to benefit patients and healthcare providers alike.
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