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 improve, monitor and measure 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.It includes a wide range of activities related to process improvement, ensuring all work is completed accurately within specified time frames, and making sure high levels of customer service are always provided. At the direction of the QC Operations Manager, coordinate and execute all aspects of QC engineering/operation activities including assisting with advisories and improvements.Responsibilities: Promote and execute quality standards, inspection processes, test methodology, quality plans, documents and reports.Devises sampling procedures and designs and develops forms and instructions for recording, evaluating, and reporting quality and reliability data.Perform routine and non-routine inspection/characterization to support release, and QC testing of raw materials, production intermediates and finished products.Identify and drive the development and implementation of activities/methods to improve first pass yield and turnaround time to support operational objectives.Developing and validating testing methodology. Setup, revising and updating Standard Operating Procedures, system or processes to improve material/process specifications/test methodology.Constantly review procedures and processes and work closely with key internal partners to provide recommendations for improvements. Develop procedures, work instructions, guidance, best practice protocol such as checklists and troubleshooting guidelines.Compiles and writes training material and conducts training sessions on quality control activities.May perform troubleshooting on discrepancy observed in laboratory or material as necessary.Ensure that the lab processes are compliant with Quality System and EHS requirements.Assignments include areas such as leading, troubleshooting, nonconformances evaluation, incoming & outgoing inspection improvement, CAPA, material control, process & system enhancement and drive sustaining activities to meet QC goals, etc.Assignment may include but not limited to evaluation of non-conformance material, method improvement to incoming and outgoing inspection, calibration, analytical or bio-molecular QC assays to support release, characterization and stability testing of raw materials, production intermediates and finished products etc.Work in accordance with procedures and integrated program plans for achieving and maintaining the required level of product quality in preparation for FDA and ISO third party audits.Works on problems of diverse scope where analysis of data requires review and interpretation of identifiable factors. Demonstrates solid judgment in selecting methods and techniques for obtaining solutions.Provide guidance to quality technicians related to incoming/outgoing inspection.Ability to resolve escalated issues encountered to drive resolution and alignment with cross function.Other such duties that may be determined by Management.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.Preferred Educational Background: BSc or MSc Degree in Engineering or Science.>3 years of relevant working experience in manufacturing environment.Experience with QC processes and application of various biochemical assays or analytical tools.Good understanding of FDA regulatory environment (CFR 820), 510k and ISO 13485 strongly preferred.Experience in medical device/ pharmaceutical/ IVD is preferred.Experience in supporting manufacturing operations, or QC/QA operations. Individual with CQE is a plus.Experience with data mining, trend analysis, control charting, statistical analysis.Demonstrate leadership as a change agent.May have experience with leading method development/ NPI transfer projects independently.Preferred Requirements:Ability to apply experience in meeting requirement of FDA Quality /System Regulations and/ or ISO 13485 Standard.Able to interpret engineering drawing for mechanical commodity – hardware, metal and plastic parts.Demonstrate critical path thinking and ability to breakdown scientific issues to draw experiment design.Effective failure investigation, technical report writing, data mining, trend analysis, statistical analysis.Intermediate to advanced experience with words processing and spreadsheets, charting, graphing tools and presentation tools.May have experience with electronic production life (PLM), enterprise resource planning tools (SAP) etc.May have experience with statistical analysis packages, eg, JMP, Minitab.Must be detailed oriented, well organized and able to work independently and in teams.Highly effective planning, prioritization, organization, and implementation skills.Intermediate to advanced level of knowledge in GD&T, QC Tool, FMEA, Cpk, Gauge R&R.Ability to identify areas of improvement and devise, plan and implement solutions.Developing project management skills.Establishes working relationships across functions. Employs internal working relationships to influence business objectives.Ability to design and deliver training to others regarding work processes and/or quality system elements.Knowledge and skills typically acquired through previous positions in fast-paced corporate environments which involved responsibility for similar work.Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs.Illumina believes that everyone has the ability to make an impact, and we are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information.
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