Quality Engineer II

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Description

Position Summary :

Ensures, through global and local Product Development Process procedures and efforts, that Molecular products are developed, tested and transferred to manufacturing according to established procedures that will assure that they meet all quality requirements.Responsible for the implementation and maintenance of effective Quality Systems in accordance with FDA Quality Systems Regulation, ISO 9001, ISO 13485 and other applicable country specific regulations. Participates and provides guidance to quality improvement teams on tools, techniques and management systems for quality assurance, compliance, and continuous quality improvement. Primary Duties :

• Perform all work in compliance with company quality procedures and standards.
• Quality Engineering Support for the Molecular R&D Design Control Process – Design, approve, and implement development effort / project planning as needed, review and approve project documentation as requested.
• Represent the Quality R&D function by participating in design reviews, developing quality engineering deliverables and assuring Design History File (DHF) is updated and reviewed for accuracy / completeness when necessary.
• Provide guidance / support to program directors, project managers, product development teams, R&D, and Product Validation functions regarding application of design controls, scalability, and related development process practices and improvements.
• Contribute to the documentation of quality systems and programs in the area of training, change management, design control, including product verification and validation, CAPA for relevant design issues, documentation control considerations, etc. to ensure compliance with FDA and regulatory requirements.
• Develop and execute design control training programs (e.g. design change control, risk analysis, etc. as requested).
• Prepare for and support regulatory and agency inspections / audits (FDA / ISO / MDSAP / etc.), investigations, and inquiries regarding the control and assessment of product design quality. Support corporate / internal design control audits.
• Participate in site R&D CAPA activities and non-conformities / deviations including investigation, effectiveness, and root cause analysis, etc. Coordinate implementation of corrective actions and preventive measures, as needed.
• Function as QA subject matter expert for cross-functional development team related practices : facilitate risk management activities, provide guidance for strategy and content of requirements and specifications. Provide strategies and approvals for verification methodologies, configuration management, validation, and regression testing approaches.
• Ensure the maintenance of the Risk Management File of the products in your portfolio

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