Design Quality Engineer 2 - NPI

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.

Design Quality Engineer 2

Summary

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.

Key Responsibilities

• Provides Quality oversight to ensure the company'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
• Supports product risk management activities
• Supports audits to ensure the quality and completeness of product Design History Files and/or Device Master Record
• Gains understanding of applicable technology to facilitate participation in the technical discussions and risk-based decision making
• Provides project Quality lead and/or management with status updates on assigned responsibilities and goals and escalate issues in a timely fashion
• Gains Understanding of 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.
 

Qualifications Minimum Requirements

• Bachelor's Degree Engineering and/or Science Degree, preferred
• Master's Degree Advanced degree without experience; or equivalent work experience
• 2 - 5 years of related experience
• 1 - 3 years Experience working within FDA/ISO regulated industry

Preferred Qualifications

• Quality Certification (e.g. CQE) will be advantageous
• Knowledge of FDA regulatory environment (CFR 820), 501k, ISO 14971, ISO 13485 and IVDR preferred
• 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) 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

Illumina believes that everyone has the ability to make an impact, and 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.