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 th