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:In this cross functional Quality role, you will lead a process development initiative to improve the scalability Product Quality Complaint reporting. Provide quantitative and analytical insight on product quality as part of Illumina’s Quality Complaint team for Complaint Data ManagementThis position is responsible for the implementation and reporting for product quality of customer issues for field product Investigations. This high visibility role will be responsible in execution & presenting Global Complaint Measurement reporting to key product stake holders on Illumina’s Medical Devices and provide advanced analytical support and appropriate data to assist quality Leadership in developing their strategies and drive leading-edge thinking. This will include the include creation, development, and maintenance of requirements for measurement models & KPI’s for automated reporting of quality systems data. The job will require working closely with Technical Data Engineering and Data Analysts teams, along with enterprise solution teams for effective scaling complaint measurement program development.Responsibilities:Develop and manage a integrated quality process for complaint investigation measurement and effectiveness for Quality investigations on field product quality issue.Develop and manage product KPI’s and trend reports to Operations and Quality management teams in the areas of field product quality for design control, purchasing controls, risk management, software controls and manufacturing controls.Provide ongoing quality reporting to executive management of customer product quality issues and ad-hoc complaint analysis of field issues and past problem history.Develop reporting capability for oversight for identify, assess and track potential adverse events and/or field actions.Develop reporting capability to Identify, escalate, initiate, participate, facilitate, and/or support complaint investigations and CAPA activities.Support cross function team for scaling product measurement process for process quality complaint data to improve product and process; develop recommendations based on data analysis.Develop effectiveness and ROI measurement process of complaint investigations through CAPA records for corrective actions.Provide consultation to end users and process owners regarding data collection, analysis and creation of reports.Ensure product complaints meet requirements of FDA and ISO when applicable.Take initiative to identify and drive improvements to the Illumina quality system.Requirements:8-10+ years' recent experience in a Product Quality role for continuous product or process improvementPossess strong analytical skills with a focus on systems & process scalability.Strong presentation skills, including the ability to influence process change via interpersonal skills.Minimum of 2-4 years' experience with Tableau or Power BI required or other data visualization requiredApplied experience with quality and statistical analysis tools (e.g. SPC, 6 Sigma, Risk Analysis, FMEA, DOE, and trend analysis)Experience with product design, product performance for intent post market surveillance and measurementKnowledge of quality regulations and standards (21CFR820, ISO 13485, ISO 9001, ISO 14971, and/or IVDD, health hazard evaluation, product risk safety analyses, MDR/Vigilance and field action reporting)Adaptable to fast-paced, dynamic work environment with shifting demands.Demonstrated ability to accomplish goals while working across departments is required.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.Education:Bachelor’s degree or equivalent experience required; engineering or technical science discipline preferred.The estimated base salary range for the Staff Business Analyst - Product Complaints role based in the United States of America is: $113,600 - $170,400. Should the level or location of the role change during the hiring process, the applicable salary range may be updated accordingly. Compensation decisions are dependent on several factors including, but not limited to, an individual’s qualifications, location where the role is to be performed, internal equity, and alignment with market data. Additionally, all employees are eligible for one of our variable cash programs (bonus or commission) and eligible roles may receive equity as part of the compensation package. We offer a wide range of benefits as innovative as our work, including access to genomics sequencing, family planning, health/dental/vision, retirement benefits, and paid time off.At Illumina, we strive to foster a diverse and inclusive workplace by cultivating an environment in which everyone contributes to our mission. Built on a strong foundation, Illumina has always been rooted in openness, collaboration, and seeking alternative views and perspectives to propel innovation in genomics. We are proud to confirm a zero-net gap in pay, regardless of gender, ethnicity, or race. We also have several Employee Resource Groups (ERG) that deliver career development experiences, increase cultural awareness, and demonstrate our collective commitment to diversity and inclusion in the communities we live and work. 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. If you require accommodation to complete the application or interview process, please contact accommodations@illumina.com. To learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf
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