To assist in maintaining Quality Assurance and Control practices in adherence to the Food and Drug Administration (FDA) regulations for the Quality System Regulation and for ISO 13485 standards, the QA Specialist is responsible for managing complaint handling, returned goods tracking, and reporting requirements. The QA Specialist will be responsible for working with Engineering, Manufacturing and Quality Assurance to coordinate the activities required for investigation including failure analysis, nonconformance and CAPA related to complaints. The position requires reporting returns to regulatory agencies as required and close investigations within appropriate timeframes.
• Manage the complaint investigation process end-to-end.
• Work with other teams in a collaborative environment to complete the end-to-end complaints process in a highly regulated environment.
• Document product return and/or complaints as well as the results of investigations in a timely manner.
• Interface with customers and internal employees for reporting of complaints and returned goods.
• Document the analyses of product complaints for trends and identification of potential corrective or preventive actions.
• Report product complaints to appropriate regulatory agencies as required.
• Serve as a member of the internal audit team and implement/assist in implementing corrective and preventive actions.
• Recommend improvements in quality system to ensure that the quality system is efficient and effective controls are in place to minimize risk.
• Complete projects in a timely manner and consistent with corporate objectives.
• Bachelor’s degree in engineering, clinical sciences, related sciences is preferred.
• 1+ year of post-market complaints experience in a medically regulated industry with an understanding of appropriate global medical device regulations, requirements, and standards such as ISO 13485 and FDA QSR.
• Medical Device and or other regulated industry (Pharma, IVD,) preferred.
• Must be able to work as a team to gather information needed to understand and solve problems
• Experience in Technical Writing
• Experience with creation and writing procedures or policies
• Advanced computer skills preferred
• Quality Management software knowledge preferred
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Diversity is a part of ZEISS. We look forward to receiving your application regardless of gender, nationality, ethnic and social origin, religion, philosophy of life, disability, age, sexual orientation or identity.
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