Sr Design Quality Engineer

In this cross functional quality role, you will actively participate in design control activities, including research and diagnostic applications. You will ensure product and process conformance to applicable safety and quality system regulations and standards (e.g. FDA (820), ISO 13485, ISO 14971, IVDR). You will be responsible for guiding teams through the execution of design control activities in alignment with quality system requirements and current best practices to ensure the company's products and processes are safe, effective, and meet customer performance needs. You will represent quality on cross functional project teams., Provides Quality oversight to ensure Illumina's products and processes are safe, effective, and meet customer performance needs throughout the product lifecycle

• Provides support for project planning, requirements/specifications development, design verification and validation, design transfer, process development, process validation, risk management, and/or human factors
• Ensures products meet appropriate regulatory requirements (e.g. FDA, IVDR, ISO) in compliance with the quality management systems
• Leads product risk management activities
• Audits the quality and completeness of product Design History Files and/or Device Master Record
• Facilitates participation in the technical discussions and risk-based decision making utilizing knowledge of applicable technology
• 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)
• Other such duties that may be determined by Management

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.

Bachelor's Degree in Engineering or Science field with 5+ years of related experience, or Master's Degree with 3+ years of related experience

• PhD Engineering and/or Science Degree with 2+ years experience, PhD Engineering and/or Science Degree with 2+ years experience
• Quality Certification (e.g. CQE) Upon Hire
• Technical expertise in products such as reagents, consumables, assays, instruments preferred
• Knowledge of quality and statistical analysis tools (e.g. SPC, Six Sigma, Risk Analysis, FMEA, DOE, statistical comparison tests, and trend analysis)
• Knowledge of FDA regulatory environment (CFR 820), 501k, ISO 14971, ISO 13485 and IVDR preferred
• Highly effective communication, facilitation, coaching, and negotiation skills
• Adaptable to fast-paced, dynamic work environment with shifting demands
• Must be detailed oriented, well organized and able to work independently and in teams

The estimated base salary range for the Sr Design Quality Engineer role based in the United States of America is: $90,000 - $135,000. Should the level or location of the role change during the hiring process, the applicable base pay range may be updated accordingly. The range reflects long-term growth in the role. Most candidates are hired between the minimum and middle of the range. Placement depends on experience, skills, location, and internal equity. 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 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.