The right job isn’t about location or benefits or responsibilities. The right job is about personality, character, motivation, and fulfillment. It’s about what inspires us, what we’re passionate about.
At Fluidigm, we’re passionate about life. Exploring it, studying it, sustaining it, living it. We make biotech tools that enable our customers and ourselves to seek truth in applied life sciences. To push limits and envision ever more creative answers to “what if…?”
Naturally, we’re also passionate about people, especially the ones we work with. We know that the right people in the right positions can do amazing things, and we love helping that happen.
Now we’re looking for a well-rounded and knowledgeable QA Specialist III to join our Quality Assurance team.
Essential Duties and Responsibilities
Be responsible for overseeing the Risk Management program, including risk assessment in the product development process and complaint handling process.
Be responsible for overseeing the Change Control program, including changes to product and document control.
Participate in product development teams as the voice of QA.
Participate in corporate CAPA processes, including corrective and preventive action, nonconformance reporting, and customer complaint handling.
Participate in the audit program (internal/external) and assist in third-party (regulatory and customer) inspections and audits to ensure compliance and ongoing certification/registration.
Assist with the continual improvement of the Fluidigm Quality Management System at the SSF site and across other sites.
May be called upon to review batch records and disposition of product for reagent manufacturing in-process and finished goods.
Have fun, be fully engaged and promise to have a life beyond “work”.
Technical Degree (BS or higher) in a biological or chemical science and 3-5 years of experience working within/developing Quality Systems in compliance with ISO, FDA and European regulations/standards; additional experience (5-10 plus years) may be accepted in lieu of a degree.
Prior experience managing/overseeing risk management (ISO 14971) and change control required.
Recent (within two years) hands-on auditing experience (internal, external, third-party).
The ability to work across the organization with all levels of employees to ensure that the value of the Quality Programs are understood and embraced.
ISO 13485:2016 lead auditor certification a plus.
Exposure to reagents and instruments is a plus.
Experience with in vitro diagnostic medical device product preferred.
If this sounds like you, we will:
Deliver superior compensation, benefits and opportunities for career growth.
Engage you in a dynamic and rewarding company culture.
Support you in your ongoing development and contribution both as an employee and a person.
Value your contribution and enlist your feedback.
Host excellent company-wide events multiple times a year.
Offer onsite yoga classes, massages, randomly free and good food, friendly greetings, gym equipment and, seriously, a lot more!
Internal Number: 2018-2746
About Fluidigm Corporation
Fluidigm creates and manufactures innovative technologies and life science tools designed to revolutionize biology through a relentless pursuit of scientific truth. Its core technologies, based on microfluidics and mass cytometry, enable the exploration and analysis of individual cells as well as the industrial application of genomics.
Most microfluidics experts in the 1990s worked with rigid substances such as silicon, glass or plastic, but a young Stephen Quake, PhD, endeavored to create complex microplumbing from a novel rubber substrate. He and co-inventor Marc Unger created multilayer soft lithography, which allowed the development of integrated microscopic valves to control the flow of fluids within microchannels—and a new approach to biological liquid handling was born.
Meanwhile, Gajus Worthington, a college classmate of Quake’s, was acquiring the skills and experience necessary to build a successful company. Mentored in his early 20s by thought leaders such as Jim Collins, he set upon his personal mission to create an organization that would make lasting contributions to science and technology. In 1999, Worthington and Quake united the possibilities of Quake’s breakt...hrough with the desire to enable ever greater biological discoveries and co-founded Fluidigm. Today, the company’s integrated fluidic circuits (IFCs) offer rapid, efficient, highly parallel and reproducible multistep sample preparation and analysis of up to hundreds of genetic markers across thousands of samples in just hours, rather than days or weeks, allowing analysis of DNA, RNA, protein and epigenetics all the way down to the level of the individual cell.
Fluidigm microfluidic technology supports genomics-based applications such as single-cell gene expression, high-throughput SNP genotyping, protein expression analysis, digital PCR, mutant detection and more. Additionally, two of the company’s instruments have proven to be workhorses within the life science industry: the Biomark™ HD and C1™ systems.
Introduced in 2006 and updated in 2011, Biomark HD stands alone in the world of analytical instrumentation as a multi-application platform without compromise, providing high-quality results for every experimental approach. Since its debut in 2012, the C1 system has been revolutionizing single-cell research. The C1 allows users to rapidly and reliably isolate, phenotype and process individual cells for genomic analysis to survey tissue heterogeneity, identify critical rare cell populations, validate molecular pathways, characterize gene regulation and identify genetic variants.
By enabling systems-level biology at single-cell resolution, the C1 provides researchers with an unparalleled understanding of normal development, disease progression and the effects of therapeutic treatment. Select Biosciences, an independent research company, said in its January 2011 report on single-cell analysis (SCA) that "Fluidigm is the leading microfluidics company for SCA ... [and] Fluidigm is well-positioned to become a leader in SCA."
By 2013 the company’s position in the single-cell movement was clear: Independent research firm DeciBio, in its report “Single Cell Genomics (SCG): Market Size, Segmentation, Growth, Competition and Trends,” identified Fluidigm as the "undisputed leader in single-cell genomics." Meanwhile, the publisher of the journal Nature declared single-cell sequencing its Method of the Year.
In 2014 Fluidigm expanded into single-cell proteomics with its acquisition of technology leader DVS Sciences, the inventor of CyTOF®, a multiparameter single-cell protein analysis system. This technology utilizes antibodies tagged with transition metal atoms to label specific proteins on cells; the CyTOF 2 mass cytometer quantifies the transition metals using time-of-flight mass spectrometry. The precision of mass cytometry allowed the use of much larger panels, making high-parameter cytometry a reality and solidifying the company’s position at the leading edge of single-cell biology. That year Fluidigm also launched Juno™, which affordably scales next generation sequencing (NGS) DNA library prep through bench top automation with integrated thermal cycling. The system produces dozens to hundreds of sequencer ready amplicon libraries covering thousands of genomic target regions each.
The year 2015 marked a new high in the number of major Fluidigm product introductions. The company unveiled Callisto™, an automated cell culture system; Helios™, an enhanced CyTOF instrument; the high-throughput C1 mRNA Seq HT IFC; and Polaris™, whose unified workflow from cell selection to molecular analysis enables direct examination of how cellular environment relates to gene expression. In addition, Time magazine named Juno one of the 25 best inventions of the year.
Today more than 500 people work for Fluidigm worldwide. The company works with more than 1,000 valued customers pioneering the field of single-cell biology or using applied genomics in industrial applications to improve and protect our food supplies, track samples in the world's largest biobanks and in general provide faster, more accurate, lower-cost workflows to help improve people's lives.
Fluidigm is headquartered in South San Francisco, California, with sales and sales support operations from Beijing to Tokyo to Paris to San Francisco. Fluidigm conducts its research and development activities and manufactures its instruments, integrated fluidic circuits and reagents in its factories in South San Francisco, Singapore and Markham, Ontario.