Summary :
We are seeking a highly motivated and detail-oriented New Product Development (NPD) Quality Engineer to join our team. This role is embedded within a cross-functional core team and plays a critical part in both ensuring compliance and driving efficiency in the design and development lifecycle. The primary focus of this position is to streamline and optimize design control processes to support the efficient and compliant development of In Vitro Diagnostic (IVD) products, including Research Use Only (RUO), IVD-CE marked, and clinical diagnostic products intended for global markets.
The successful candidate will bring hands-on experience as a Quality Engineer supporting product development, along with a demonstrated ability to improve and scale quality processes. The role spans reagent systems, complex instrumentation, and software/informatics platforms across both New Product Introduction (NPI) and sustaining activities. This individual will collaborate closely with R&D, Regulatory Affairs, and Operations to implement right-sized, risk-based design control frameworks that balance agility for RUO products with regulatory rigor for clinical and IVD-labeled products.
Responsibilities:
- Serve as the Quality representative on cross-functional teams for continuous improvement of NPD quality processes and tools.
- Collaborate with external and internal partners to define product requirements, intended use, and clinical performance criteria.
- Ensure compliance with design control processes per FDA 21 CFR Part 820, ISO 13485, and IVDR.
- Support risk management activities (ISO 14971), including hazard analysis, FMEA, and risk mitigation strategies.
- Support verification and validation (V&V) planning and execution, including analytical and clinical performance studies.
- Review and approve design documentation, including DHF elements, specifications, and test protocols.
- Lead and coordinate supplier qualification, incoming inspection, and quality oversight of critical components.
- Drive root cause analysis and CAPA for design-related issues during development and transfer.
- Support regulatory submissions (e.g., PMA, 510(k), IVD-CE marking, China) with quality documentation and technical input.
Minimum Requirements:
- Bachelor’s degree in Engineering, Life Sciences, or related field.
- Minimum 5 years of experience in Quality Engineering within the IVD or medical device industry.
- Strong experiencein design control, risk management, and regulatory standards (FDA, ISO, IVDR, China).
- Experience working in cross-functional teams and managing external partnershipsutilizing excellent communication, documentation, and problem-solving skills.
Preferred Skills/Knowledge:
- Master’s degree in Engineering, Life Sciences
- Experience in Software quality assurance
- ASQ certification in Lean Six Sigma Green Belt/Black Belt
- Experience in flow cytometry instruments and/or clinical assays.
