Analog Devices - Wilmington, MA
posted 3 months ago
About the position
As a Senior Medical Quality Engineer at Analog Devices, Inc., you will play a pivotal role in ensuring operational excellence within the Medical Products Quality Team. Your primary focus will be on developing and implementing internal quality management systems that include metrics tracking, analysis, reporting, and problem-solving to facilitate ongoing process improvements. You will coordinate with various stakeholders, including management, manufacturing engineering, regulatory, and product management, to address all issues related to quality assurance and compliance. In this role, you will be responsible for creating and updating the medical Quality Management System processes and tools in accordance with ISO 13485 standards and 21 CFR (Code of Federal Regulation) 820 specifications. You will also develop training programs to support the Medical Quality Management System (MQMS) processes and manage the Corrective Action and Preventive Action Process (CAPA), including necessary US FDA reporting. Your expertise will be crucial in defining and managing the Process Change Review and Material Review, as well as managing non-conformance and deviation reporting processes with ADI partners, which may involve communication with the FDA as necessary. You will establish Documentation Control and Records processes that comply with the Computer System Validation requirements for 21 CFR Part 11 and support or maintain Internal Audit programs in accordance with ISO 13485. Additionally, you will host third-party audits, including those from the FDA, and manage the execution of corrective actions identified in the internal audit program. Your advisory support will be essential for FDA submissions for ADI's emerging and new medical products, and you will monitor performance data to drive continuous improvement during Management Reviews. Your role will also involve ensuring effective Risk Management by utilizing feedback from validation, post-market surveillance, manufacturing indicators, and CAPA. You will lead problem-solving teams through root cause investigations and failure analysis, participating in the development and results analysis of quality validation plans in new product designs and processes. Furthermore, you will provide support for FDA and other governmental or ISO Notified Body inspections, assisting with corrective action and remediation plans as needed.
Responsibilities
- Engage with Medical Products Quality Team to ensure operational excellence regarding improvements and strategy.
- Develop and implement internal quality management systems, including metrics tracking, analyzing, reporting, and problem-solving for ongoing process improvements.
- Coordinate and serve as technical representative with management, manufacturing engineering, regulatory, and product management on all issues related to quality assurance and compliance.
- Create and update the medical Quality Management System processes and tools in accordance with ISO 13485 standard and 21 CFR (Code of Federal Regulation) 820 specification.
- Develop training programs to support the Medical Quality Management System (MQMS) processes.
- Manage Corrective Action and Preventive Action Process (CAPA) including US FDA reporting as necessary.
- Support the definition and management of the Process Change Review and Material Review.
- Manage non-conformance and deviation reporting processes with ADI partners, including communication with the FDA as necessary.
- Establish Documentation Control and Records processes that meet the Computer System Validation requirements for 21 CFR (Code of Federal Regulation) Part 11.
- Support and/or maintain Internal Audit programs in accordance with ISO 13485 and host third-party audits, including FDA.
- Manage the execution of corrective actions identified in the internal audit program.
- Provide advisory support for FDA submission for ADI emerging and new medical products.
- Support Management Reviews data collection and monitor performance to drive continuous improvement.
- Support the definition and maintenance process for medical product design history files.
- Ensure effective Risk Management utilizing feedback from validation, post-market surveillance, manufacturing indicators, and CAPA.
- Demonstrate an understanding of the audit process, including types of audits, planning, preparation, execution, reporting results, and follow-up.
- Lead problem-solving teams through root cause investigations and failure analysis to implementation and final verification.
- Participate in the development and results analysis of quality validation plans in new product designs and processes.
- Provide support for FDA and other governmental or ISO Notified Body inspections, including pre- and post-inspection support.
Requirements
- Progressive 5+ years of experience in the medical products industry, including experience in leadership roles in related fields or a combination of equivalent education and relevant experience.
- BS in Electrical Engineering, Mechanical Engineering, Biomedical Engineering, Process Engineering, or related technical disciplines; an MS degree is preferred.
- Demonstrated experience in quality oversight and management of products through the lifecycle of product development.
- Experience supporting quality systems, practices, and policies.
- Familiarity with regulatory requirements including US CFR, ISO, GMP, and EU MDR.
- Knowledge of FDA 510(k) clearance, FDA Premarket Approval (PMA), and ongoing submission maintenance requirements.
- Experience with the use of quality systems and tools (e.g., CAPA, Six Sigma methodology, change control, Statistical Analysis, Control Plans, and document management).
- Experience supporting Risk Management, for instance, ISO 14971 standard.
- Experience directing root cause analysis using quality tools, such as 5 Why, Fishbone Analysis, and Fault Tree Analysis.
Benefits
- Flexible and dynamic work environment
- Opportunities for personal and professional growth
