Summary : This role ensures that Client' IVD products meet stringent regulatory requirements and quality standards. The Staff Quality Engineer will lead quality engineering initiatives, support product development and manufacturing processes, and drive continuous improvement in the quality management system.
Roles & Responsibilities - Develop, implement and maintain quality systems and processes in compliance with FDA CFR Part 820, ISO 13485, IVDR 2017/746, ISO 14971and other regulations, as appropriate, for IVD products
- Conduct hazard analysis and risk assessments forIVD products according to ISO14971 throughout the IVD product lifecycle
- Lead internal and external audits, including preparation, execution, and follow-up to ensure adherence to quality and client standards and regulatory requirements
- Oversee corrective and preventive action (CAPA) processes, non-conformance investigations and deviations to resolve quality issues
- Collaborate with cross-functional product development teams to integrate quality requirements into product design, verification and validation activities according to Design Controls
- Review and approve design control documentation including design inputs, design outputs, verification/validation protocols and reports, and risk management documentation.
- ssess and qualify new suppliers in product development and throughout the product lifecycle.
- Establish and maintain Design History File for IVD products
- Establish, monitor and analyze quality metrics, trends and performance data to identify areas of improvement
- Support regulatory submissions and activities for IVD product approvals
- Support complaints process (review, process, investigate, trend quality data,etc. ) and post-market incident activities.
- Support post-market incident activities
- Manage post-market incident activities (field action, MDRs, EU incident decision/reporting, field failure trending).
- Maintain knowledge of laboratory regulatory requirements, including accrediting bodies, federal, state, and local requirements as well as Client policies.
- Drive continuous improvement initiatives in design control and risk management processes, leveraging industry best practices, lessons learned, and feedback from audits and post-market surveillance dat
- Stay current with evolving regulatory requirements, standards, and industry trends
- Proactively update internal processes, policies and procedures, and training materials as needed
- Drive continuous improvement initiatives in design control and risk management processes, leveraging industry best practices, lessons learned, and feedback from audits and post-market surveillance dat
- Stay current with evolving regulatory requirements, standards, and industry trends
- Proactively update internal processes, policies and procedures, and training materials as needed
- Follow corporate policies and procedures
- Perform other duties as assigned.
Education & Experience: - 8+ yearsof experience in Medical Devices and/In Vitro Diagnostics (IVD) design and development with a strong focus on design control and risk manageme
- Experience in working effectively in an FDA-regulated environmentExperience working with IVD products
- nalytical mindset with attention to detail and a commitment to integrity, product safety, and Quality
- Demonstrated Experience applying medical device regulations (e.g.IEC 62304, FDA 21 CFR Part 803, 21 CFR Part 806, 21 CFR Part 820, ISO 13485, ISO 14971, IVDR, CAP, and CLIA).
- Experience with quality management system development, Design Controls, and risk management
