Design Quality Engineer 2

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., Provide Quality oversight to ensure Illumina's products and processes are safe, effective, and meet customer performance needs throughout the product lifecycles

• Provide support for project planning, requirements/specifications development, design verification and validation, design transfer, process development, process validation, risk management, and/or human factors
• Ensure products meet appropriate regulatory requirements (e.g. FDA, IVDR, ISO) in compliance with the quality management systems
• Lead product risk management activities
• Audit the quality and completeness of product Design History Files and/or Device Master Record
• Facilitate participation in the technical discussions and risk-based decision making utilizing knowledge of applicable technology
• Support issue resolution using a risk-based approach
• Provide management with status updates on assigned responsibilities and goals and escalate issues in a timely fashion
• Utilize quality and statistical analysis tools (e.g. SPC, Six Sigma, Risk Analysis, FMEA, DOE, statistical comparison tests, and trend analysis)
• Define and/or create processes to align with quality standards and business practices

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 Engineering and/or Science Degree, preferred

• Master's Degree Advanced degree without experience; or equivalent work experience
• PhD Advanced degree without experience; or equivalent work experience
• 2-5 years of related experience
• 2-5 years experience working within FDA/ISO regulated industry, Quality Certification (e.g. CQE) Upon Hire
• Technical expertise in areas such as Assay Development, Bioinformatics, MFG Quality Engineering, Clinical Trials, Instrument Development (with a focus on CMOS and MEMS) preferred
• Knowledge of quality and statistical analysis tools (e.g. SPC, Six Sigma, Risk Analysis, FMEA, DOE, statistical comparison tests, and trend analysis) preferred
• Knowledge of FDA regulatory environment (CFR 820), 501k, ISO 14971, ISO 13485 and IVDR preferred
• Team oriented with excellent communication skills
• Excellent cross-functional collaboration
• Must be detailed oriented, well organized and able to work independently and in teams
• Adaptable to fast-paced, dynamic work environment with shifting demands

The estimated base salary range for the Design Quality Engineer 2 role based in the United States of America is: $74,900 - $112,300. 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 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.