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Illumina · 1 day ago

Design Quality Engineer 2

San Diego, CA

Full-time

Onsite

Entry, Mid Level

$75K/yr - $112K/yr

2+ years exp

Illumina is a company focused on expanding access to genomic technology to promote health equity globally. The Design Quality Engineer 2 will be responsible for ensuring product and process compliance with safety and quality regulations, guiding teams in design control activities, and providing quality oversight throughout product lifecycles.

BiotechnologyGeneticsHealth CareMedical

No H1B

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

Qualification

FDA regulationsISO standardsQuality CertificationStatistical analysis toolsRisk managementTeam orientedCommunicationCross-functional collaborationDetail orientedAdaptable

Required

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

Preferred

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