Sr Quality Engineer (Design Control/Product Development)

Illumina, Inc
Job Location
800 Saginaw Drive
Redwood City, CA 94063
market salary DOE, bonus potential, equity

PTO, ESPP, 401k, medical/dental/vision, etc.

Job Description

Basic Function and Scope of Position:
This position will lead and/or support in vitro diagnostic (IVD) design and development activities, focusing on driving strategy and documentation requirements throughout the product life cycle process for multiple concurrent projects. 

The position will manage design and development plans (DDP), traceability matrices, risk management activities, phase review requirements, design/process/clinical verification and validation plans/protocols/reports, design history file (DHF) compilation, design change, design transfer, and post market surveillance. 

The position will support driving continuous improvement of the quality management system. 

Ideal candidates will have superior knowledge of design control/product development, risk management, ISO 13485, ISO 14971, 21 CFR 820, IVDD.  A Quality Engineering/Quality Assurance background and a strong understanding of medical device design controls in a regulated environment.  

Tasks and Responsibilities: 

•    Provide design control/product development strategy guidance to cross-functional team
•    Act as QA lead on project sub-teams (i.e. Operations, Clinical, Development, Commercial, etc.)
•    Develop and drive design and development plans (DDP)
•    Develop and drive Traceability Matrices
•    Coordinate and drive phase deliverables with cross-functional product development team
•    Drive documentation requirements throughout product development process
•    Manage compliance and completion of DHFs
•    Ensure compliance with regulatory requirements and internal policy and procedures
•    Assist in ensuring Quality Systems are established, implemented, and maintained in compliance with all appropriate regulatory standards, including federal, state and local
•    Coordinates or assists in coordinating regular quality systems meetings reviewing quality metrics 
•    Participates in Product Quality reviews, management reviews and preparation of quality reports
•    Establishes/updates procedures related to the product development process including design control.


Preferred Educational Background:

B.S. Degree in Molecular Biology or related field
Preferred Experiential Background:

•    6+ years of QA industry experience; in vitro diagnostic or molecular reagent quality assurance (quality engineering experience preferred.)
•    A firm understanding of Quality Systems, FDA Quality System Regulations and ISO Standards (ISO 13485, ISO 14971, ISO 15189) are required. Familiarity with CAP regulations, CLIA regulations and HIPPA are highly desired.
•    Experience as the team lead for 3rd party and regulatory (FDA, ISO) audits is required. Experience with CAP, NY, CLEP and any additional agencies would be beneficial.
•    Excellent problem solving and analytical skills.
•    Effective interpersonal and communication skills and capable of supporting cross-functional project goals.
•    Possess an understanding of the fundamental principles and concepts of molecular biology, genetics, and how these relate in a clinical setting.
•    Careful and accurate documentation of work.

EOE / Minorities / Females / Veterans / Disabled

How to Apply

Apply on-line for job ID 2741BR through our web site's careers page:

About Our Organization

Headquartered in San Diego, California, Illumina (NASDAQ: ILMN), is a leading developer, manufacturer, and marketer of next generation life science tools and integrated systems for large-scale analysis of genetic variation and biological function. These systems are enabling studies that were not even imaginable just a few years ago, and moving us closer to the realization of personalized medicine. With the innovative advances in our sequencing technologies, we are rapidly impacting the clinical market in areas such as reproductive health and oncology. The expanding Illumina oncology portfolio of next- generation sequencing NGS and microarray technologies is revolutionizing cancer genomics research. Our customers include a broad range of academic, government, pharmaceutical, biotechnology, and other leading institutions around the globe.

lllumina has experienced phenomenal growth from $10 million in revenues in 2002 to over $1.4 billion in 2013. Forbes named Illumina #1 on the 2009 list of 25 Fastest-Growing Technology Companies in the United States, the second time over a three year period that Forbes ranked Illumina #1 on its list of rapidly growing technology companies. Illumina was also named #1 smartest company in the world as part of MIT’s 2014 Technology Review.  As of August 2014, the company had a $24 billion market capitalization.

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