Job Title: Senior Quality Engineer, In Vitro Diagnostics

• Location: Cambridge, MA
  

About the Job

The Senior Quality Engineer – In Vitro Diagnostics is a senior subject matter expert responsible for ensuring the quality, safety, and regulatory compliance of IVD’s 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: Provide strategic quality leadership across IVD development, evidence generation, labeling, regulatory strategy, and lifecycle management, ensuring compliance with FDA and international regulatory requirements, including EU IVDR, ISO 18113, and 21 CFR Part 809. Support global regulatory submissions and conformity assessment activities for diagnostic, biomarker, patient selection, and companion diagnostic programs, including PMA, 510(k), IDE, IND, NDA, and BLA submissions, as well as EU IVDR Technical Documentation reviews and Notified Body interactions. Review analytical validation, clinical performance, and assay data to support regulatory decision-making, including SR/NSR and IDE determinations. Ensure quality oversight of Technical Documentation, Performance Evaluation Reports, and GSPR compliance, maintaining traceability between intended use, risk management, performance evidence, labeling, and regulatory claims while supporting inspection readiness and successful regulatory outcomes.

• End-to-End Lifecycle Quality: Provide quality leadership across assay development, validation, design transfer, commercialization, and lifecycle management, ensuring compliance with design controls and maintaining traceability from intended use and user needs through verification, validation, risk management, clinical evidence, and labeling. Maintain Design History Files (DHF), Technical Documentation, and Technical Files while overseeing analytical validation and performance evaluation activities, including scientific validity, analytical performance, and clinical performance. Ensure risk management principles consistent with ISO 14971 are integrated throughout the product lifecycle and provide quality oversight for clinical studies, post-market surveillance activities, and continuous monitoring of diagnostic product performance.

• Laboratory and Clinical Study Quality: Establish and maintain quality frameworks for internal and external laboratories, CROs, and diagnostic partners; lead laboratory qualification activities including assessments, audits, quality agreements, performance monitoring, and inspection readiness; ensure compliance with applicable standards and regulations; and provide quality oversight of biomarker, patient-selection, companion diagnostic, and laboratory-developed assays, including review of validation packages for fitness-for-purpose.

• Supplier & Partner Quality: Conduct supplier qualification, audits, and monitoring, and oversee the quality aspects of IVD development, validation, patient testing, and diagnostic activities 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 Qualifications

• Bachelor’s degree in engineering, Biomedical Engineering, Biochemistry, Molecular Biology, Analytical Chemistry, or any field

• 10+ years in quality management within IVD or closely related diagnostic fields.

Preferred Qualifications

• Advanced degree (MS/PhD)

• Strong leadership experience

• Hands-on experience with assay development and validation

• Laboratory quality systems implementation and management

• Clinical and performance study support

• Direct experience with diagnostic, biomarker, and patient selection assays and companion diagnostic programs

• Proven track record building or transforming QMS in developing organization

• Experience supporting IVDs from concept through commercialization

• Manufacturing operations experience

• Drug-device combination products knowledge

• 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 capabilities

• 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

The salary range for this position is:

All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can