Senior Quality Assurance Engineer
hace 1 mes
Quality Assurance Role at Cardinal Health
We are seeking a skilled Senior Quality Assurance Engineer to join our team at Cardinal Health. As a Quality Lead for Complaint Investigations, you will be responsible for leading quality assurance processes at our assigned facility. Your duties will include diligent and thorough analysis, investigation of product complaints, and leading process improvement activities for complaint investigations.
Key Responsibilities:
- Perform device analysis in accordance with model-specific procedures and protocols.
- Provide statistical support and analytical problem-solving to identify root causes of problems.
- Respond to complaints and non-compliance, and sign off on deviations, validation, and other design verification protocols.
- Conduct trending analysis with non-conformance compliance and develop month-end reports and management reviews.
- Develop corrective and preventative actions for quality-related processes.
- Serve as an internal auditor and support external audits.
- Perform other duties in line with business needs.
Requirements:
- 2-4 years QA complaint handling experience in medical devices.
- Bachelor's degree in a related field or equivalent work experience.
- Knowledge of FDA and ISO 13485 regulations and standards.
- Advanced fluency in English.
- Demonstrated ability to work effectively with cross-functional teams for complaint investigation and root cause analysis.
- Thorough knowledge of relevant GMPs and Good Documentation Practices.
- Strong analytical skills.
- Proficient in Microsoft Office tools such as Word, Excel, PowerPoint, and Outlook.
- Proficiency in Minitab.
- Ability to thrive in a dynamic environment.
About Us:
Cardinal Health is a distributor of pharmaceuticals, a global manufacturer and distributor of medical and laboratory products, and a provider of performance and data solutions for healthcare facilities. We are a crucial link between the clinical and operational sides of healthcare, delivering end-to-end solutions and data-driving insights that advance healthcare and improve lives every day.
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