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Director, Quality Assurance
3 weeks ago
Element Science Redwood City, United StatesSUMMARY OF ROLE · :We are seeking an experienced and dynamic Director of Quality Assurance to join our team. As the Director of Quality Assurance, you will play a pivotal role in ensuring the quality, safety, and compliance of our medical devices. You will lead a team of quality ...
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Director, Quality Assurance
3 days ago
KARIUS Redwood City, United States Full timeAbout Karius Karius is a venture-backed life science startup that is transforming the way pathogens and other microbes are observed throughout the body. By unlocking the information present in microbial cell-free DNA, we're helping doctors quickly solve their most challenging cas ...
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Director, Quality Assurance
5 days ago
Element Science Inc Redwood City, United StatesDIRECTOR, QUALITY ASSURANCE · THE COMPANY: · Element Science, Inc. is a medical device and digital health company focused on developing solutions at the intersection of clinical-grade wearables, machine learning algorithms, and lifesaving therapies in order to address leading cau ...
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Director, Quality Assurance
5 days ago
Adept Source Redwood City, United StatesTitle: Director, Quality Assurance, Pharma · Location: Redwood City, CA (hybrid model) · Type of role: FTE, Full time Salary: plus bonus and equity · Our start-up Biotech client is seeking an Associate Director / Director Quality Assurance to join their growing company. Ideal can ...
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Director, Quality Assurance
17 hours ago
AdeptSource Redwood City, United StatesTitle: Director, Quality Assurance, Pharma · Interested in this role You can find all the relevant information in the description below. · Location: Redwood City, CA (hybrid model) · Type of role: FTE, Full time Salary: plus bonus and equity · Our start-up Biotech client is s ...
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Senior Quality Assurance
3 days ago
Revolution Medicines, Inc. Redwood City, United StatesRevolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit high-value frontier targets in RAS-addicted cancers. The company's R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic varian ...
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Director, Quality Assurance
2 days ago
Karius, Inc. Redwood City, United StatesAbout Karius Karius is a venture-backed life science startup that is transforming the way pathogens and other microbes are observed throughout the body. By unlocking the information present in microbial cell-free DNA, we're helping doctors quickly solve their most challenging cas ...
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Quality Assurance
17 hours ago
FlutterFlow San Mateo, United StatesAs a Quality Assurance (QA) Lead at FlutterFlow you will be at the forefront of ensuring our products meet and exceed our user's expectations. This role is designed for professionals with a keen eye for detail, a passion for enhancing user experiences, and a deep knowledge of sof ...
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Sr. Manager, Quality Assurance
1 week ago
BioSpace, Inc. San Carlos, United StatesJoin our Mission to Protect Humankind · Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked. Working to e ...
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Quality Assurance Specialist II
3 weeks ago
Gilead Sciences Foster City, United States RegularJob Description · At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therap ...
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Sr. Manager, Quality Assurance
4 days ago
Vaxcyte San Carlos, United StatesJoin our Mission to Protect HumankindVaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked. Working to eradi ...
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AD/Director, Quality Assurance
6 days ago
Adept Source Redwood City, United StatesTitle: AD/Director, Quality Assurance, Pharma · Location: Redwood City, CA · Type of role: FTE, Full time Salary: 181K - 214K plus bonus and equity · Our direct client is seeking an Associate Director / Director Quality Assurance to join their growing company. · Job DescriptionDe ...
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AD/Director, Quality Assurance
17 hours ago
AdeptSource Redwood City, United StatesTitle: AD/Director, Quality Assurance, Pharma · Before applying for this role, please read the following information about this opportunity found below. · Location: Redwood City, CA · Type of role: FTE, Full time Salary: 181K - 214K plus bonus and equity · Our direct client i ...
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Mgr, Quality Assurance
2 weeks ago
Natera San Carlos, United StatesPOSITION SUMMARY: · Manager, Quality Assurance is responsible for supporting the quality management system, compliant with CAP, CLIA, NYS DoH, 21 CFR Part 820, and ISO This position tracks quality performance and makes decisions concerning quality issues by working directly with ...
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Mgr, Quality Assurance
2 weeks ago
Natera San Carlos, United StatesPOSITION SUMMARY:Manager, Quality Assurance is responsible for supporting the quality management system, compliant with CAP, CLIA, NYS DoH, 21 CFR Part 820, and ISO This position tracks quality performance and makes decisions concerning quality issues by working directly with cro ...
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Mgr, Quality Assurance
1 week ago
Natera San Carlos, CA, United StatesPOSITION SUMMARY:Manager, Quality Assurance is responsible for supporting the quality management system, compliant with CAP, CLIA, NYS DoH, 21 CFR Part 820, and ISO This position tracks quality performance and makes decisions concerning quality issues by working directly with cro ...
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Clinical Quality Assurance
3 weeks ago
ICONMA San Mateo, United StatesAssociate Director, Clinical Quality Business Partners, Laboratory Compliance, R&D Quality & Medical Governance (Foster City, CA)We are looking for an expert Quality Assurance Professional with experience advising research and development teams in Good Clinical Laboratory Practic ...
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Director, Quality Assurance
3 weeks ago
Element Science Inc Redwood City, United StatesTHE COMPANY: · Element Science, Inc. is a medical device and digital health company focused on developing solutions at the intersection of clinical-grade wearables, machine learning algorithms, and lifesaving therapies in order to address leading causes of death and hospitalizat ...
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Quality Assurance Engineer
1 week ago
SLAC National Accelerator Laboratory Menlo Park, United StatesQuality Assurance Engineer · Job ID · 5940 · Location · SLAC - Menlo Park, CA · Full-Time · Regular · SLAC Job Postings · Position Overview: · The primary purpose of the Quality Assurance Engineer (QAE) position at SLAC is part of the Contractor Assurance and Contract Ma ...
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Quality Assurance Engineer
3 weeks ago
SLAC National Accelerator Laboratory Menlo Park, United StatesQuality Assurance Engineer · Job ID · 5902 · Location · SLAC - Menlo Park, CA · Full-Time · Regular · SLAC Job Postings · Position Overview: · SLAC Contractor & Quality Assurance group is seeking a Quality Assurance Engineer (QAE). The primary purpose of the Quality Assu ...
Quality Assurance - San Carlos, United States - Q Bio
4 weeks ago
Description
Quality Assurance & Regulatory Affairs Lead Q Bio is building technology for the Physical of the Future that measures more, faster and cheaper about the human body, to enable proactive primary care for all.
We're revolutionizing primary care with the first clinical digital twin platform, powered by breakthrough whole-body scanning technology, that highlights the most important changes in a persons physiology for sharing with physicians and specialists anywhere in the world.
Q Bios clinical digital twin platform, Gemini, is the first to capture and monitor comprehensive baseline patient health in a scalable virtual model.
The Gemini Dashboard highlights the most important chemical and anatomical changes in an individual weighted by an individuals lifestyle, genetic and medical history, that can be securely shared with physicians and specialists all over the world.
Gemini is powered by the fastest, most accessible, whole body scanner developed:the Mark I.
Self-driving and optimized for primary care, the Mark I can complete a whole-body scan in 15 minutes or less in an open space, without radiation, breath holds, or claustrophobia.
Patient comfort is maximized with the option to sit, stand, or lie down, and real-time telemetry is displayed throughout.Why should you consider a career with Q Bio?We dream big.
Our team is aligned and excited about the opportunity to save lives and understand the human body like never before.
We know how critical empowering and supportive leadership is, both to our excellence as a company, and for our team experience as a whole, and our leadership team will empower and support career growth.
Were a team of engineers, scientists, and operators who come from a diverse background of disciplines and experiences.We value teamwork, growth, determination and persistence, commitment to collaboration, and a reliance on staying nimble while keeping the big picture in mind.
We are looking for an experienced Regulatory Affairs & Quality Assurance Lead to oversee our Mark I whole-body scanner regulatory submission and maintain market authorisation for our Gemini digital twin platform for compliance and commercial viability.
You will be an important member of our leadership and product team.Responsibilities include:
Oversee all regulatory submissions for medical devices (both hardware and software) and partner with leadership on appropriate regulatory product roadmapsOrganize and coordinate scientific data, relevant documents, and prepare 510(k) submission of a Class 2 medical devicePresent and communicate with relevant regulatory agencies and carry out any subsequent negotiations necessary to obtain or maintain marketing authorisation for products concernedCollaborate with Engineering team and Technical Program Manager(s) for all proper documentation and provide guidance on appropriate processesManage and coordinate with external counsel, advisors, and relevant research agenciesQualifications Experience and prior success in leading 510(k) submissionsDetail-oriented and strong organizational skillsAbility to prioritize and stay focused in a dynamic environmentExcellent communication and team collaboration skillsStrong desire to learn new topics related to the assigned technologiesWillingness to be hands-on and be both player/coachIndependent and proactive driver in their field of expertiseIn the San Francisco Bay Area, the standard pay range for this role is $160,000-$200,000 annualized.
This pay range is for the San Francisco Bay Area and is not applicable to locations outside of this location or for remote roles.
Actual amounts will vary depending on experience, performance, and work location. In addition to a competitive base salary, we offer significant equity and an employee-friendly stock option plan.Employees will also be eligible to participate in benefits plans available to other similarly situated employees subject to any eligibility requirements imposed by such plans.
Q Bio was founded in 2015 by serial entrepreneur Jeffrey Kaditz, Dr. Michael Snyder, Chair of Genetics and Director of Personalized Medicine at Stanford University, and Dr. Garry Choy, physician, radiologist, and former Chief Medical Information Officer at Mass General Hospital.Q Bio has raised over $80M from world class investors including Andreessen Horowitz, Kaiser Foundation Hospitals, Khosla Ventures, Founders Fund, SciFi VC, and many more.
Q Bio is an Equal Opportunity Employer and we value diversity at our company.We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
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