Senior Design Quality Engineer
As a Senior Design Quality Engineer, you will provide QA technical and compliance expertise to teams establishing customer needs, developing new products, and modifying existing designs. You will assure compliance to applicable regulations and lead quality activities such as risk assessments, device testing, audits, procedure development, documentation review, and changes to controlled documents.
Responsibilities:
* Ensure Cerenovus Design control and Risk Management activities comply with requirements of the Cerenovus Design Control and Risk Management processes.
* Provide Quality support and guidance to R&D project leads and team members.
* Direct and support Design Assurance engineers and Quality Engineers.
* Coordinate Design Assurance Engineer resources to support Cerenovus business objectives.
* Resolve project issues by working with team members, suppliers, and others as appropriate.
* Apply thorough, systematic problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues.
* Manage and maintain records related to design control projects.
* Contribute and participate in design review meetings.
* Provide input into generation of risk management file documents, including Risk Management Plan, dFMECA, pFMECA, and associated reports.
* Provide input into development of protocols and reports supporting the Design control process.
* Review and provide input on protocols and reports for sterilization, biocompatibility, and packaging validations.
* Coordinate timely review and approval of all details in R&D batch sterilization records to meet requirements of the cycle validated and appropriate for the Cerenovus product.
* Coordinate timely review and approval of production records and sterilization records of product manufactured during the design control process to facilitate timely approval of Design protocols and reports.
* Support bench test activity as required.
* Translate design requirements into manufacturing requirements.
* Monitor data from Quality Management systems and provide immediate feedback to quality management on deviations or issues of concern.
Requirements:
* Minimum 5 years' experience in the medical device industry and/or IVD/pharmaceutical, with at least three years in a position with direct responsibility for QMS processes/sub-processes.
* Demonstrated knowledge of the application of the principles, concepts, and practices of design control, sterilization, and Quality Assurance processes.
* Experience in preparation, participation, and response to external agency inspections, e.g., FDA and Notified Body Inspections.
* Thorough knowledge of Design Control requirements and processes.
* Working knowledge of 21 CFR 820, ISO13485, and familiarity with other foreign medical device quality system requirements.