Quality Engineer III
Thermo Fisher ScientificSalary not specified
- Full Time
- Junior (1 to 2 years)
$60,000 – $80,000Compensation
Mid-level (3 to 4 years), Junior (1 to 2 years)Experience Level
Full TimeJob Type
UnknownVisa
Medical Devices, Pharmaceuticals, Quality EngineeringIndustries
Requirements
Candidates should possess a Bachelor’s degree in Engineering, Biology, or a related scientific field, and have at least 5 years of experience in quality engineering, preferably within a regulated environment such as medical devices or pharmaceuticals. Strong knowledge of CAP, CLIA, FDA, and ISO 13485 standards is required, along with experience in risk analysis and root cause analysis.
Responsibilities
The Staff Design Quality Engineer will provide Quality oversight to ensure Illumina’s services and processes are safe, effective, and meet customer performance needs throughout the product lifecycles. They will also provide guidance on implementation and support continuous improvement of the Quality Management System (QMS), product development, and Software Development Lifecycle (SDLC) activities, as well as support project planning, requirements/specifications development, verification and validation, design transfer, process development, process validation, and risk management. This role involves auditing the quality and completeness of product Design History Files and supporting internal and external audits, leading workflow risk management activities, and expertly guiding software compliance, design control, and providing quality leadership to the product development teams to identify compliance gaps and develop strategies to close them.
Skills
CAP
CLIA
FDA
ISO 13485
Risk Analysis
Root Cause Analysis
Quality Management System (QMS)
Software Development Lifecycle (SDLC)
Design Control
Verification
Validation
Auditing
Risk Management
Compliance
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.
Key Metrics
San Diego, CaliforniaHeadquarters
1998Year Founded
$27.2MTotal Funding
IPOCompany Stage
Venture Capital, BiotechnologyIndustries
5,001-10,000Employees