Design Quality Engineer 2

Illumina•San Diego, CA

35d

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
1-3 years of related experience
1-3 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, Shop Floor Operations, 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

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