Quality Systems Engineering Manager

Analog Devices, Inc. (NASDAQ: ADI) is a global semiconductor leader that bridges the physical and digital worlds to enable breakthroughs at the Intelligent Edge. ADI combines analog, digital, and software technologies into solutions that help drive advancements in digitized factories, mobility, and digital healthcare, combat climate change, and reliably connect humans and the world. With revenue of more than $12 billion in FY22 and approximately 25,000 people globally working alongside 125,000 global customers, ADI ensures today’s innovators stay Ahead of What’s Possible.

Responsibilities:

• Manage the Medical Products Quality Team with a focus on ensuring 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 the contact 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.
• Manage and perform 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.
• Coordinate Management Reviews to monitor performance and drive continuous improvement.
• Support the definition and maintenance process for medical product design history files.
• Guide cross-functional teams to ensure product quality objectives are met.
• Coordinate and serve as the contact with contract organizations or service providers related to quality aspects.
• Ensure effective Risk Management utilizing feedback from validation, post-market surveillance, manufacturing indicators, and CAPA (Corrective Action and Preventive Action).
• 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. Support activities may include interacting with inspectors/auditors, obtaining information, and assisting with corrective action and/or remediation plans.

Required skills to have for this role:

• Progressive 8+ 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 (Code of Federal Regulation), ISO (International Organization for Standardization), GMP (Good Manufacturing Practice), and EU MDR (Medical Device Regulation).
• Knowledge of FDA 510(k) clearance, FDA Premarket Approval (PMA), and ongoing submission maintenance requirements.
• Experience with the use of quality systems and tools (for example, 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.

For positions requiring access to technical data, Analog Devices, Inc. may have to obtain export licensing approval from the U.S. Department of Commerce - Bureau of Industry and Security and/or the U.S. Department of State - Directorate of Defense Trade Controls. As such, applicants for this position – except US Citizens, US Permanent Residents, and protected individuals as defined by 8 U.S.C. 1324b(a)(3) – may have to go through an export licensing review process.

Analog Devices is an equal opportunity employer. We foster a culture where everyone has an opportunity to succeed regardless of their race, color, religion, age, ancestry, national origin, social or ethnic origin, sex, sexual orientation, gender, gender identity, gender expression, marital status, pregnancy, parental status, disability, medical condition, genetic information, military or veteran status, union membership, and political affiliation, or any other legally protected group.

EEO is the Law: Notice of Applicant Rights Under the Law.

Job Req Type: Experienced

Required Travel: No

Shift Type: 1st Shift/Days