Design Quality Engineer 2

Illumina • San Diego, CA

21h

About The Position

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.

Requirements

• 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
• 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

Nice To Haves

• 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

Responsibilities

• 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

Benefits

• 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.
• We also have several Employee Resource Groups (ERG) that deliver career development experiences, increase cultural awareness, and offer opportunities to engage in social responsibility.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees