Senior Design Quality Engineer

What if the work you did every day could impact the lives of people you know? Or all of humanity?

At Illumina, we are expanding access to genomic technology to realize health equity for billions of people around the world. Our efforts enable life-changing discoveries that are transforming human health through the early detection and diagnosis of diseases and new treatment options for patients.

Working at Illumina means being part of something bigger than yourself. Every person, in every role, has the opportunity to make a difference. Surrounded by extraordinary people, inspiring leaders, and world changing projects, you will do more and become more than you ever thought possible.

Position Summary:
This position is responsible for Quality activities that measure, monitor, and improve Illumina’s compliance with the Quality System Regulations, Illumina Quality policies, FDA regulations and ISO standards as well as Illumina product quality for current operation and compliance objectives.

Position Responsibilities:
- Execute New Product Introduction (NPI) and Product Transfer related tasks to ensure operation readiness for NPI/Transfer, including creation and setup of related documentation.-
- Identify product performance potential risks, performing root cause analysis of failures, and implementing effective solutions to mitigate these risks.- Work closely with cross-functional teams to ensure that reliability is built into products from the early stages of development through to their operational use.- Work closely with cross-functional teams to review and assess engineering change/qualification/validation documentation, ensuring impact/risk/validation status of the manufacturing equipment/process and production line are taken into consideration.- Design methods and procedures for inspecting, testing and evaluating the precision and accuracy of production processes, production equipment and finished products.- Perform analysis of reports and production data to identify trends and recommend updates or changes to quality standards and procedures when necessary.- Constantly review quality control processes and drive improvements that can be implemented to improve product quality performance to enhance customer satisfaction, reduce maintenance costs, and improve overall product performance.- Provide quality assurance support, review and approvals to areas of manufacturing operations, product development, or field / product quality.- Assignment may include but not limited to overseeing processes such as non-conformance, product quality issue, incoming and outgoing inspection, return material authorization, calibration, etc.- Ensure facilities, equipment, materials, processes, procedures and product readiness to comply with cGMP practices.- Interact with various personnel levels and departments to ensure compliance with FDA, MDSAP, IVDR, ISO rules and regulations, including audit/inspection readiness.
- All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities as determined by Management._

Position Requirements:
- Bachelor’s degree in Bio-engineering, Chemistry Engineering or relevant field.- Typically requires a minimum of 5 years of related experience with a Bachelor’s degree; or 3 years and a Master’s degree; or a PhD without experience; or equivalent work experience.- Minimum 3 years of working experience in highly regulated manufacturing environment, with knowledge of FDA Quality System Regulations and/or ISO 13485 Standards.- Experience in project transfer/NPI and product quality knowledge.- Strong knowledge of quality system, tools and methodology skills in statistical analysis including Statistical Process Control (SPC).- Strong analytical, problem-solving and decision-making skills.- Detailed oriented, well organized and able to work independently and collaboratively.- Certified Quality Engineer (CQE) certification is highly advantageous.- Experience in medical device/IVD is preferred.- Experience with words processing, spreadsheets, charting, graphing, and presentation tools.- May have experience with electronic enterprise systems such as Product Lifecycle Management (PLM), Enterprise Resource Planning (e.g. SAP), etc.- May have experience with statistical analysis packages, e.g., JMP, Minitab.