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 Supplier Quality Engineer who will play an integral role in supporting quality activities related to Supplier Quality Management (SQM) in accordance with FDA QSR (Quality System Regulation), ISO 13485, and other medical device/IVD regulations. This individual also supports various QMS activities that comply with the FDA QSR, ISO 13485, as well as CLIA/CAP requirements for the clinical laboratories. This position will report to the VP of Quality Assurance.
- Implement and own Supplier Quality Management (SQM) program.
- Responsible for the supplier compliance of audits, Supplier Quality Agreements (SQA), SCARs, supplier surveys/questionnaires, and Supplier Request for Information (RFI).
- Supplier monitoring:
- Develop, monitor and report meaningful SQM performance metrics, supplier performance/scorecard.
- Developing, measuring, improving and enforcing key processes and procedures to manage suppliers effectively.
- Ensure supplier performance meets current expectations, and improve supplier performance and productivity.
- Organize and report supplier performance and key considerations to the management team.
- Supplier selection and qualification:
- Participate in the supplier selection process, and perform supplier audits to evaluate supplier capabilities, quality systems, processes, and services.
- Perform validations and qualifications of suppliers to qualify the manufacturing process and overall quality of part/component manufacturing.
- Maintain ASL (Approved Supplier List).
- Incoming Quality Program:
- Manages incoming quality and participates in the MRB process to resolve internal and external quality audit findings related to purchased products.
- Support incoming quality requirements including development of purchase specifications, sampling plans, incoming material approval, etc.
- Ensure suppliers have adequate control plans, schedules, and resources to make continued improvements to the incoming quality of supplied products.
- Works with Engineering and Quality to ensure that incoming product specifications contain and clearly communicate the requirements needed to ensure supplied products are acceptable for manufacturing, and assist in developing inspection methods and improving sampling plans for new materials and components.
- SCAR/Corrective Actions:
- Drive supplier root cause analysis and corrective actions to prevent the recurrence of quality issues.
- Identifies non-conformance trends; develops and administers technical investigations and corrective action programs to resolve recurring quality problems.
- Collaborate with Supply Chain personnel on supplier quality activities including material procurement, incoming specification requirements, inventory control processes, and supply release criteria. Identify opportunities for supply chain improvements.
- Assist with supplier-facing change controls, deviations, supplier initiated change notifications, as well as post-market activities such as recalls, corrections, investigations and regulatory inspections.
- Provide technical assistance to suppliers/other resources performing qualification/validation testing.
- Lead and/or support other duties as assigned.
- Bachelor’s Degree in Engineering or Science field.
- 8-10 years’ experience in a QMS environment with 3-5 years working as a supplier quality engineer.
- Working knowledge of medical device / in vitro diagnostic regulations (e.g., FDA 21 CFR 820, ISO 13485, IVDD, and other applicable quality and regulatory standards).
- Experience in all aspects of supplier quality, including supplier assessments/audits, maintaining a supplier evaluation program, supplier corrective actions, and supplier process changes.
- Travel will be required up to 25% of the time, both domestically and internationally.
- 5+ years of supplier quality experience in the Life Sciences Industry, with prior experience in an FDA regulated environment.
- Have a strong background in applying statistical tools for process and product development and control, e.g. Gage R&R, Process Capability, Control Plans, SPC, Process Failure Mode Effects Analysis (PFMEA), and Design of Experiments (DOEs).
- Familiarity with (or interest in developing a knowledge of) Laboratory Developed Tests (LDTs), Companion Diagnostics (CDx), genetic (Next-Generation Sequencing - NGS) based tests; CLIA/CAP and Pharma/GCP regulations.
- Excellent organizational, interpersonal and verbal and written communication skills
- Ability to deliver quality outputs under minimal supervision.