Lead Design Quality Engineer

Lead Design Quality Assurance Engineer

Billerica, Massachusetts

We are looking for an experienced and motivated Lead Design Quality Assurance Engineer to join our Quality Assurance team. This role will provide pre‑market and post‑market Design Quality Engineering support to ensure delivery of highest quality products to the customer. The Lead Design Quality Assurance Engineer develops, establishes, and maintains quality engineering methodologies, systems, and practices that meet Quanterix, customer, and regulatory requirements.

It serves as a Quality representative to improve awareness, visibility, and communication on quality initiatives to support departmental, functional, and corporate quality goals and priorities.

• Support the New Product Development process; work with the Design History File (DHF) and Device Master Record (DMR) and ensure that design projects comply with internal design control procedures.
• Apply knowledge of Design Control and Quality Engineering principles to positively influence new product development efforts, including Voice of the Customer, establishing design inputs/outputs, Design Verification & Validation, Process Qualification & Validation, and Risk Management.
• Work with Assay Development, Instrument Engineering, Operations, Service and other teams as needed to support vendor qualification, software validation, instrument IQ/OQ/PQ and assay system validation.
• Assess post‑launch proposed design changes to determine impact on risk level, verification and/or validation testing.
• Maintain Risk Management Files in compliance with regulatory requirements and local procedures.
• Provide guidance on external compliance requirements such as Safety, EMC, RoHS, China RoHS, WEEE, Cybersecurity and represent the QA function at Design Reviews.
• Mentor peers, project team members and lower‑level Quality Engineers in the application of risk management and design control requirements and industry best practices.
• Support a wide range of continuous and process improvement initiatives, including remediation efforts, product development, and sustaining projects.
• Support other quality and compliance activities as required including supporting regulatory submissions, internal audits and inspections.
• Help to drive and foster a quality environment and mindset throughout the business.
• Support special projects as needed.

• 5+ years’ experience in a Quality function within the Medical Device, Biotechnology, Life Sciences or similar discipline arena desired.
• Minimum of a Bachelor’s Degree required in a related field (Biomedical, Software, Electrical, Mechanical Engineering or equivalent); advanced degree is a plus.
• In‑vitro diagnostic manufacturing or contract manufacturing environment (instrumentation/software and reagents) experience.

• Thorough understanding of GMP/ISO regulations (ISO 14971, ISO 13485, EN61010, IEC 62304, IVDR and 21
  
  CFR
  820).
• Able to work independently, with minimal daily guidance.
• Excellent cross‑functional team participation skills.
• Highly organized and detail oriented.
• Proficiency with standard business tools: word processing, presentations, spreadsheets, manufacturing software, database software.
• Strong work ethic and organizational skills to manage multiple projects under tight deadlines with a collaborative attitude.

• Demonstrates a strong quality mindset with the ability to align quality engineering activities to product performance, customer needs, and business objectives.
• Applies critical thinking and sound judgment to assess design changes, identify risks, and recommend practical, compliant solutions.
• Builds effective cross‑functional partnerships and influences stakeholders at all levels to drive quality and compliance objectives.
• Communicates clearly and effectively, translating complex quality and regulatory concepts for both technical and non‑technical audiences.
• Solves problems proactively using structured root cause analysis and data‑driven decision‑making to support continuous improvement.
• Provides leadership, guidance, and mentoring to peers and project teams in the…