Quality Operations Engineer at Illumina

San Diego, California, United States

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Not SpecifiedCompensation

Entry Level & New GradExperience Level

Full TimeJob Type

UnknownVisa

Biotechnology, Medical Devices, In-Vitro DiagnosticsIndustries

Requirements

0-2 years experience in quality assurance field in a regulated environment; direct experience working in in-vitro diagnostic manufacturing preferred
Knowledge and experience applying quality regulations and standards (21CFR 820, ISO 13485, ISO 14971, IVDD)
Knowledge and experience with instituting quality controls in an ERP system, SAP preferred
Highly effective communication, facilitation and negotiation skills
Adaptable to fast-paced, dynamic work environment with shifting demands

Responsibilities

Ensures adequacy of non-conformances and CAPA records, investigations, and corrective actions
Become familiar with the applicable technology to facilitate participation in technical discussions and risk-based decision making
Review equipment onboarding, calibration and preventative maintenance tickets and identify potential gaps for GMP compliance
Review change requests/notices/approvals for compliance to change requirements outlined in applicable WIs/Procedures
Develop and execute strategies to close gaps in an efficient, technical, and compliant manner
Coordinate issue resolution using a risk-based approach
Ensure manufacturing processes meet requirements of FDA and ISO
Trend, analyze, and report on quality data in order to improve product and process; develop recommendations based on data analysis
Provide management with status updates on assigned responsibilities and goals and escalate issues in a timely fashion
Collaborate with counterparts and cross-functional teams at other Illumina sites
Other activities as assigned

Skills

Key technologies and capabilities for this role

Quality AssuranceCAPAGMP ComplianceFDA RegulationsISO StandardsRisk-Based Decision MakingData AnalysisTrend AnalysisChange ControlNon-ConformancesInvestigationsCorrective Actions

Questions & Answers

Common questions about this position

What is the salary range for the Quality Operations Engineer role?

The estimated base salary range for this role in the United States is $61,700 - $92,500, with compensation decisions depending on qualifications, location, internal equity, and market data.

Is this a remote position or does it require working in an office?

This information is not specified in the job description.

What skills and experience are required for this role?

The role requires 0-2 years of experience in quality assurance in a regulated environment, preferably in in-vitro diagnostic manufacturing, knowledge of quality regulations like 21CFR 820, ISO 13485, ISO 14971, and IVDD, experience with quality controls in ERP systems like SAP, and strong communication, facilitation, and negotiation skills.

What is the company culture like at Illumina?

Illumina fosters a collaborative environment surrounded by extraordinary people, inspiring leaders, and world-changing projects, where every person has the opportunity to make a difference and become more than they thought possible.

What makes a strong candidate for this Quality Operations Engineer position?

Strong candidates will have 0-2 years in quality assurance in regulated environments, preferably IVD manufacturing, knowledge of key regulations (21CFR 820, ISO 13485, etc.), ERP experience like SAP, and excellent communication skills while being adaptable to fast-paced settings.

Illumina

Supports genomics startups through funding and resources

About Illumina

Illumina focuses on fostering innovation in the genomics industry by supporting startups through its Illumina Accelerator program. This program helps entrepreneurs create, launch, and grow genomics-focused companies by providing funding and resources. The accelerator operates in two main locations: the San Francisco Bay Area and Cambridge, UK. Illumina Accelerator has successfully invested in 68 genomics startups, which have collectively raised over $1 billion in venture capital. What sets Illumina apart from its competitors is its strong partnership with leading venture capital investors and its dedicated focus on the genomics sector. The goal of Illumina is to build a thriving ecosystem for genomics innovation, enabling new companies to emerge and advance the field.

San Diego, CaliforniaHeadquarters

1998Year Founded

$27.2MTotal Funding

IPOCompany Stage

Venture Capital, BiotechnologyIndustries

5,001-10,000Employees

Risks

Over-reliance on NVIDIA's AI technology may limit flexibility in AI solution adoption.

Standardizing proteomics data across platforms could challenge Illumina's data reliability.

Single-flow-cell NovaSeq X System might cannibalize sales of higher-end models.

Differentiation

Illumina leads in genomic sequencing with advanced AI integration and multiomic data analysis.

The company offers innovative array-based solutions for DNA, RNA, and protein analysis.

Illumina's global expansion includes a new Global Capability Center in Bengaluru.

Upsides

Collaboration with NVIDIA enhances drug discovery and clinical development through AI integration.

Pilot proteomics program with UK Biobank aims to generate crucial reference datasets.

Single-cell sequencing kits make high-throughput sequencing accessible to smaller labs.

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