Quality Systems Engineering Manager

Rakuten Medical•San Diego, CA

23h•$140,000 - $160,000

About The Position

Rakuten Medical, Inc. is a global biotechnology company developing precision, cell-targeting investigational therapies on its Alluminox™ technology platform, which utilizes antibodies conjugated with payloads that are specifically activated at the tumor site. Our first clinical product received marketing approval in Japan from the Ministry of Health, Labour and Welfare for ASP-1929 PIT to treat unresectable locally advanced or recurrent head and neck cancer - and is also in Phase III pivotal clinical testing globally to treat terminal cancer patients. This is a first-in-class product with unique pharmacological activity and with the potential to have a broad impact in cancer. Rakuten Medical is committed to its mission to conquer cancer and aims to realize a society where cancer patients can lead fulfilling lives. Headquartered in the United States, Rakuten Medical has 5 locations in 5 countries: the United States, Japan, Taiwan, Switzerland and India. For more information, visit www.rakuten-med.com . Position Summary We are seeking a highly skilled Quality Systems Engineering Manager to lead the Quality Management System (QMS) for our medical combination drug-device products. This is a critical leadership role requiring expertise in managing compliance for the development, manufacturing, and delivery of products that integrate drug and device technologies. As the QMS leader, you will shape quality strategies, drive regulatory compliance, and foster a culture of operational excellence.

Requirements

Education: Bachelor’s degree in Engineering, Life Sciences, or related field; Master’s degree or advanced certification preferred.
Certifications: ISO 13485:2016 Lead Auditor Certification (required).
Experience: Minimum 8-10 years of experience managing quality systems in regulated industries, specifically for pharmaceutical, medical devices, or combination products.
Strong working knowledge of ISO standards, FDA regulations, and international regulatory frameworks, including EU MDR (Medical Device Regulation).
Proven track record of managing complaint handling, CAPA systems, SCARs, and supplier qualification programs.

Nice To Haves

Preferred certifications: CQE (Certified Quality Engineer), RAC (Regulatory Affairs Certification).
Technical Tools: Proficiency in QMS software (e.g., Arena, MasterControl, or others).
Audit Experience: Demonstrated success leading FDA, ISO, and notified body audits with minimal findings.
Analytical mindset with strong problem-solving skills and a collaborative, team-first approach.
Travel : 10-15%

Responsibilities

Quality Management System (QMS) Leadership: Oversee the implementation, maintenance, and improvement of the QMS to ensure compliance with ISO 13485:2016, FDA 21 CFR Parts 820, 210/211, GMP, and other global regulations.
Lead Management Reviews, ensuring top-level engagement in quality objectives, process optimization, risk management, and regulatory compliance.
ISO 13485: 2016 Lead Auditor Certification: Apply expertise as a Certified Lead Auditor to conduct internal audits and prepare for external inspections by notifying bodies, regulatory authorities, and third-party auditors.
Ensure alignment with key elements of ISO 13485, including risk-based approaches, process validation, product traceability (Clause 7.5), and post-market surveillance (Clause 8.2.3).
Document Control & Arena QMS: Lead/manage document control processes utilizing Arena for product lifecycle management.
Oversee correct documentation of all quality activities required for audit readiness, including design controls, supplier files, production records, and complaint handling processes.
Supplier Quality Management: Oversee supplier qualification, monitoring, and auditing processes against medical device and pharmaceutical compliance requirements.
Manage supplier risk assessments, approve SCARs (Supplier Corrective Action Requests), and monitor CAPA implementation by external vendors.
Ensure design and process risk management using ISO 14971 for hazard analysis and product safety assessments.
Drive interdepartmental collaboration for effective QMS training and decision-making at all stages of product life.
CAPA, Non-Conformances, and SCARs: Own and manage the end-to-end CAPA and non-conformance systems, including investigation, root cause analysis, and oversight of preventive actions.
Ensure data-driven decisions using trends from SCARs, audits, and deviations to improve processes.
Training and Development: Develop robust QMS training programs to foster compliance and awareness across all functional teams, utilizing your knowledge of regulatory standards like ISO 13485, FDA requirements, and GMP/GDP.
Audit Preparedness and Leadership: Lead preparation for external audits and regulatory inspections, ensuring readiness for ISO 13485 compliance, FDA audits, and post-market audits.
Define and implement continuous improvement programs to address audit findings proactively.