Senior/Staff Quality Engineer (Assay/IVD Design Controls) at Tempus
Passionate about precision medicine and advancing the healthcare industry?
Recent advancements in underlying technology have finally made it possible for AI to impact clinical care in a meaningful way. Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real-time, actionable insights to physicians, providing critical information about the right treatments for the right patients, at the right time.
We are looking for a Senior/Staff Quality Engineer (Assay/IVD Design Controls) who will aid in the implementation of the Quality Management System framework, focus on product development, design controls, and risk management procedures.This position will report to the VP of Quality Assurance.
- Represent QA on product development teams focusing on assay, reagent, and automation development. Responsible for guiding teams through design controls.
- Lead risk management activities on cross-functional teams and ensure the required deliverables are documented properly in Design History Files (DHF).
- Collaborate with Product Development, Operations, and Supply Chain teams on the transfer of reagents and consumables to suppliers.
- Review and approve Tempus’ documentation that is consistent with design controls procedures and regulations. Documentation may include but is not limited to DHF documents such as product requirements, design and development plans, verification and validation plans and reports, design transfer documents, and risk management plans and reports.
- Lead and participate in activities to establish and maintain Tempus’s product development, design controls, risk management, and supplier management systems.
- Maintain knowledge of the evolving regulatory landscape for Laboratory Developed Tests (LDTs), Companion Diagnostics (CDx), and Next-Generation Sequencing (NGS) based tests.
- Provide quality support for internal/external inspections and product submissions/approvals as needed.
- Perform other related duties and responsibilities as assigned.
- Bachelor’s Degree in Engineering or related scientific discipline.
- 5+ years in Quality and/or Development experience in product development, product transfer, verification, validation under Design Controls in the life sciences industry, preferably in a FDA regulated medical device/IVD environment.
- Previous Quality engineering experience and demonstrated use of Quality practices and methods.
- Strong working knowledge of FDA QSR/cGMP and ISO regulations (e.g., ISO 13485).
- Strong team player with demonstrated track record of success in a cross-functional team environment.
- Ability to perform a variety of duties involving critical thinking, analysis, evaluation, and judgement in support of QMS activities.
- Ability to influence and be the voice of Quality when working with various groups in the organization.
- Manages change well. Adopts a continuous improvement orientation to the role.
- Excellent communication and interpersonal skills.