Staff 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. This position is responsible for supporting activities related to the product/test development and software development and/or implementation of in-house and third-party software systems. The position will be a core member of projects, varying in complexity, to drive compliance with internal and external procedures and regulations. In this cross functional quality role, you will actively participate in product development and transfer activities, and internal quality initiatives, ensuring product and process conformance to CAP, CLIA and ISO 13485 standards. This role will serve as a resource to software development and product development to improve product quality, reliability, and process capability. This role will also facilitate teams in identifying, documenting, assessing, correcting and preventing quality issues using risk analysis and root cause analysis tools. The position will be responsible for quality planning and establishing and maintaining metrics to improve quality system processes, process capability, reliability and quality of products. This role requires strong communication, interpersonal and organizational skills, and a solid understanding of the application of CAP, CLIA FDA and ISO 13485 standards. Responsibilities * Provides Quality oversight to ensure Illumina’s services and processes are safe, effective, and meet customer performance needs throughout the product lifecycles * Provide guidance on implementation and support continuous improvement of our QMS, Product development and SDLC activities. * Provides support for project planning, requirements/specifications development, verification and validation, design transfer, process development, process validation, risk management * Ensure product development and validation programs meet requirements of CAP, CLIA and ISO when applicable * Leads workflow risk management activities * Audits the quality and completeness of product Design History Files and supports internal and external audits * Expertly guide software compliance, design control and provide quality leadership to the product development teams, to identify compliance gaps and develop and execute strategies to close the gaps in an efficient, technical and compliant manner. * Supports issue resolution using a risk-based approach * Train, mentor software, bioinformatics, product development and Lab/clinical operations team * Provides management with status updates on assigned responsibilities and goals and escalate issues in a timely fashion * Utilizes quality and statistical analysis tools (e.g. SPC, Six Sigma, Risk Analysis, FMEA, DOE, statistical comparison tests, and trend analysis) * Defines and/or create processes to align with quality standards and business practices * Mentors lower-level Design Quality Engineers to develop skills sets 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. Requirements: * Typically requires a minimum of 8 years of related experience with a Bachelor’s degree; or 6 years and a Master’s degree; or a PhD with 3 years of experience; or equivalent experience * 8+ years of related experience * Quality Certification (e.g., CQE) is preferred * Technical expertise in products such as reagents, consumables, assays, instruments. * Applied experience with quality and statistical analysis tools (e.g. SPC, Six Sigma, Risk Analysis, FMEA, DOE, statistical comparison tests, and trend analysis) * Highly effective communication, facilitation, coaching, and negotiation skills * Experience applying quality regulations and standards (e.g. CLIA, CAP, NYDoH, ISO 13485, ISO 15189, ISO 14971) * Adaptable to fast-paced, dynamic work environment with shifting demands * Experience participating in initiatives with strong influencing skills The estimated base salary range for the Staff Design Quality Engineer role based in the United States of America is: $105,600 - $158,400. Should the level or location of the role change during the hiring process, the applicable base pay 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. Illumina conducts background checks on applicants for whom a conditional offer of employment has been made. Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable local, state, and federal laws. Background check results may potentially result in the withdrawal of a conditional offer of employment. The background check process and any decisions made as a result shall be made in accordance with all applicable local, state, and federal laws. 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. The position will be posted until a final candidate is selected or the requisition has a sufficient number of qualified applicants. This role is not eligible for visa sponsorship.