Job Title: Devie - Senior Quality Engineer, Invitro Diagnostics

• Location: Cambridge, MA

About the Job

The Senior Quality Engineer – IVD Devices is a senior subject matter expert responsible for ensuring the quality, safety, and regulatory compliance of IVD devices across the full product lifecycle—from early development through commercialization and lifecycle management. Partnering with the Senior IVD Director, this role requires deep technical and regulatory expertise including EU IVDR, FDA 21 CFR Part 809/812/820, ISO 13485, ISO 18113, and ISO 15189. The incumbent serves as a strategic quality partner to cross-functional teams including R&D, Regulatory Affairs, Manufacturing, Clinical, and Laboratory Operations, providing expert guidance on design controls, analytical validation, clinical performance evaluation, and post-market quality requirements.

Main Responsibilities

• IVD Quality Management System: Contribute to the design and implementation of  a fit-for-purpose IVD QMS aligned with ISO 13485, EU IVDR, and MDSAP. This includes working with key stakeholders to establish phase-appropriate processes spanning research, development, validation, and commercial lifecycle. Harmonize QMS practices across global functions and develops lean, scalable processes suitable for a growing organization in the IVD space.

• IVD Regulatory Compliance: system leadership across IVD design, evidence generation, labeling, and lifecycle management. Serve as primary Quality interface with FDA and EU Notified Bodies for IVD, ensuring inspection readiness within the device domain. Support regulatory submissions in the U.S. as well as EU IVDR including conformity assessments. Contribute to performance evaluation reports and technical files while ensuring strong linkage between analytical validation and labeling requirements. Ensure labeling and Instructions for Use (IFU) compliance with ISO 18113 and 21 CFR 809.10. Drive global regulatory harmonization, anticipate Notified Body expectations, and integrate compliance requirements into design processes from early development.

•  End-to-End IVD Lifecycle Quality: Provide quality leadership across assay design, development, verification, validation, and commercial manufacturing. Ensure traceability from user needs through design inputs, outputs, validation, and clinical evidence. Drive consistent application of design controls and DHF/Technical File management. Oversee analytical performance studies (sensitivity, specificity, precision, linearity, interference, reference intervals). Contribute to technical documentation/design dossier, performance evaluation (scientific validity, analytical performance, clinical performance), support clinical evidence /studies (when required), Post-Markey Surveillance, risk management (ISO14971), Interactions with laboratories (ISO 15189)

• Laboratory & Clinical Study Quality: Establish quality frameworks for internal development laboratories and external partner labs/CROs ensuring compliance with CLIA, CAP, and ISO 15189. Lead quality oversight for IVD clinical performance studies including protocol review, site qualification, monitoring, and data quality. Ensure alignment with ISO 20916 and regulatory requirements.

•  Supplier & Material Quality: Conduct new vendor audits, qualification and monitoring, and overseeing the quality aspects of IVD development, validation and patient testing performed by third parties

•  Post-Market Quality & Continuous Improvement: Establish and manage nonconformance, deviation, CAPA, complaint handling, and vigilance reporting systems. Define and implement post-market performance follow-up (PMPF) strategies. Drive continuous improvement through data-driven quality metrics.

•  Cross-Functional Collaboration: Work closely with IVD development teams, Regulatory Affairs, Clinical, and Laboratory Operations. Balance scientific understanding with quality rigor and business objectives to support IVD commercialization and lifecycle management

About You

Basic Qualification

• Bachelor's degree in Engineering, Biomedical Engineering, Biochemistry, Molecular Biology, Analytical Chemistry, or related scientific discipline, with 10+ years in quality management within IVD or closely related diagnostic fields.

• Advanced degree (MS/PhD) preferred

• Minimum 1 year in regulatory affairs or quality management systems for IVD medical devices is preferred

• Strong leadership experience required

• Hands-on experience with assay development and validation

• Laboratory quality systems implementation and management

• Clinical and performance study support

• Direct experience with Analyte Specific Reagents and Companion Diagnostics

• Proven track record building or transforming QMS in developing organization

• Experience supporting IVDs from concept through commercialization

• Additional Preferred Experience:

• Manufacturing operations experience

• Drug-device combination products knowledge

Technical Skills:

• Quality Management Systems & Regulatory Compliance:

• In-depth knowledge of ISO 13485:2016, EU IVDR (2017/746), FDA 21 CFR Part 820 (QSR), and 21 CFR Part 809 (IVD regulations)

• Proven track record implementing and certifying QMS systems across multiple sites

• Working knowledge of MDSAP (Medical Device Single Audit Program) requirements

• Comprehensive GxP knowledge and experience in implementation and maintenance of compliant systems

• IVD-Specific Standards & Requirements:

• Strong expertise in ISO 18113 series, ISO 15189, and CLSI guideline

• Knowledge of IEC 62304 (software lifecycle) and IEC 62366-1 (usability engineering) for IVD products with software/SaMD components

• Understanding of ISO 14971 risk management principles applied to IVD devices

• Experience with technical documentation, performance evaluation, and post-market obligations under EU IVDR

IVD Development & Validation:

• Demonstrated experience with design controls and DHF/Technical File management for IVD devices

• Hands-on experience with analytical performance studies (precision, accuracy, linearity, interference, reference interval studies)

• Experience with process validation (IQ/OQ/PQ), analytical method validation, and design transfer for IVD manufacturing

• Knowledge of assay development lifecycle and validation requirements

• Risk Management & Problem Solving:

• Proficiency in risk management tools and methodologies (FMEA, FTA, risk-benefit analysis)

• Strong problem-solving methodologies and root cause analysis capabilitie

• Experience with complaint handling, MDR/vigilance reporting, and post-market surveillance systems

Emerging Technologies:

• Familiarity with SaMD quality considerations including algorithm validation, cybersecurity, and AI/ML-based IVD products

• Ability to navigate complex global regulatory environments and drive organizational alignment

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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