-
Quality Engineer
3 days ago
GCM Union City, United StatesJob Type Full-timeDescriptionGCM is a global contract manufacturing company with locations in the Silicon Valley, Chicago and China, servicing MedTech, Aerospace, and industrial end-market applications. At GCM, we believe our most valuable assets are our awesome employees, who ar ...
-
Quality Engineer
14 hours ago
RJO Consulting Union City, United StatesJob Description · Job DescriptionGreetings, · Our client in Union City/Fremont area, CA is hiring a Quality Engineer I. This is a full time employee position with great opportunity to work on challenging assignments and grow your career. · REPORT TO: Direction of Quality · SUMMAR ...
-
Quality Engineer
4 days ago
GCM Union City, United StatesJob Type · Full-time · Description · GCM is a global contract manufacturing company with locations in the Silicon Valley, Chicago and China, servicing MedTech, Aerospace, and industrial end-market applications. At GCM, we believe our most valuable assets are our awesome employe ...
-
Senior Quality Engineer
2 days ago
BillionToOne Union City, United StatesDo you want to join one of the fastest-growing molecular diagnostics startups and be a pioneer for an industry-leader who is impacting the lives of millions? · Come help lead our world-class QARA team and bring your career to the next level working alongside some of the most insp ...
-
Quality Improvement Engineer II
14 hours ago
RJO Consulting Union City, United StatesJob Description · Job DescriptionSUMMARY: · The Quality Improvement Engineer II is responsible for analyzing trends, determining underlying causes · to systemic quality deficiencies, and leading improvement projects. Responsibilities also include creating · process metrics, coo ...
-
Senior Quality Engineer
3 weeks ago
BillionToOne Union City, United StatesDo you want to join one of the fastest-growing molecular diagnostics startups and be a pioneer for an industry-leader who is impacting the lives of millions? · Come help lead our world-class QARA team and bring your career to the next level working alongside some of the most ins ...
-
Quality Engineer
4 days ago
CaptiveAire West Union, United StatesCompany Profile: · CaptiveAire is the nation's leading manufacturer of commercial kitchen ventilation systems, and now provides a complete solution of fans, heaters, ductwork and HVAC equipment. For over 40 years, we've led the industry with innovative technologies, unmatched se ...
-
Quality Engineer
2 weeks ago
KnowHireMatch New Hampton, United StatesJob Title: Quality Engineer · Please ensure you read the below overview and requirements for this employment opportunity completely. · Location: New Hampton, Iowa · Salary: $75-100K · Job Summary: The Quality Engineering focuses on product launches and continuous improvement of ...
-
Continuous Improvement Quality Engineer
6 days ago
CaptiveAire West Union, United StatesCompany Profile:CaptiveAire is the nations leading manufacturer of commercial kitchen ventilation systems, and now provides a complete solution of fans, heaters, ductwork and HVAC equipment. For over 40 years, weve led the industry with innovative technologies, unmatched service, ...
-
Quality Engineer- New Hampton Iowa
1 week ago
MorningStar Recruitment New Hampton, United StatesARE YOU SEEKING A NEW CHALLENGE WITH A COMPANY THAT WILL APPRECAITE YOU AND REWARD YOU? · Job Summary: The Quality Engineering focuses on product launches and continuous improvement of the Quality Management System. Use customer requirements, APQP/PPAP processes and ISO 9001 QMS ...
-
Reliability Excellence Manager
1 week ago
Blommer Chocolate Company Union City, United StatesJob Purpose: · The Reliability Excellence Manager provides day-to-day leadership, supervision, and direction for the engineering and maintenance teams to ensure a safe, efficient, cost-effective operating facility. Provides technical support for continuing operations focusing on ...
-
Research Associate
2 weeks ago
Celltheon Corporation Union City, United StatesCompany Description · Celltheon Corporation, located in Union City, CA, is a technology company specializing in Cell Engineering. With its CHOK-1 derived SUPERCELLTM cell line and unique DNA and RNA vector elements, Celltheon offers solutions for recombinant biotherapeutics, incl ...
-
Manufacturing Process Engineer
1 week ago
FOXSEMICON TECHNOLOGY LLC Union City, United StatesPosition: Manufacturing Process Engineer Hours: 40 hours per week · Position Summary · We are looking for a talented manufacturing engineer to oversee and improve manufacturing processes. The manufacturing engineer's responsibilities include identifying areas for improvement, m ...
-
Reliability Excellence Manager
1 week ago
Blommer Chocolate Union City, United StatesJob Purpose: · The Reliability Excellence Manager provides day-to-day leadership, supervision, and direction for the engineering and maintenance teams to ensure a safe, efficient, cost-effective operating facility. Provides technical support for continuing operations focusing on ...
-
Development Project Manager
5 days ago
Outform Union City, United StatesJob Summary · The Development Project Manager is responsible for managing and developing permanent display projects/jobs initiated by our Sales team. It is the DM's responsibility to disseminate the information from Sales and to lead the development of the project/job from begi ...
-
Manufacturing Engineer
14 hours ago
RJO Consulting Union City, United StatesJob Description · Job DescriptionSUMMARY: · Responsible for the creation, revision, and control of manufacturing and standard work documentation. Applying lean and six sigma tools to eliminate waste, improve quality, and create continuous flow in all areas of manufacturing. · PRI ...
-
Sr. Electrical Engineer
2 weeks ago
Amber Kinetics Inc Union City, United StatesSr. Electrical Engineer - System Validation · Validate and test Flywheel Energy Storage System include establishing test plan, design test setup, hardware test setup, choose and install instrumentation such as oscilloscope, sensors, DAQs, managing data streams, and report result ...
-
Process Engineer
2 weeks ago
Legrand Union City, United StatesPosition Description · At a Glance · Legrand has an exciting opportunity for a Process Engineer to join the Finelite Team in Union City, CA. · The process engineer's responsibilities include identifying areas for improvement, maintaining high levels of manufacturing and produc ...
-
Sr. Electrical Engineer
1 week ago
Amber Kinetics Inc Union City, United StatesSr. Electrical Engineer – System Validation · Validate and test Flywheel Energy Storage System include establishing test plan, design test setup, hardware test setup, choose and install instrumentation such as oscilloscope, sensors, DAQs, managing data streams, and report result ...
-
Development Project Manager
14 hours ago
Outform, Inc. Union City, United StatesJob Description · Job Description90, ,000.00 · Job Summary · The Development Project Manager is responsible for managing and developing permanent display projects/jobs initiated by our Sales team. It is the DM's responsibility to disseminate the information from Sales and to le ...
Sr. Quality Engineer - Union City, United States - BillionToOne
Description
Do you want to join one of the fastest-growing molecular diagnostics startups and be a pioneer for an industry-leader who is impacting the lives of millions?Come help lead our world-class QARA team and bring your career to the next level working alongside some of the most inspiring leaders in the industry.
BillionToOne, ranked at the top 5% of Y Combinator companies with $300M+ in funding from prominent VC firms, has developed a DNA molecular counter that increases cfDNA diagnostic resolution by over 1,000 fold.
BillionToOne's first product, UNITYTM is the first and only non-invasive prenatal test that can directly screen an unborn baby and assess its risk for common and severe recessive gene disorders and chromosomal abnormalities, as well as fetal sex and fetal antigens, from a single tube of blood from the pregnant mother without paternal testing.
In 2023, BillionToOne launched two liquid biopsy products that will markedly improve oncology treatment and care.With Northstar SelectTM, clinicians will be able to select cancer therapies that will be most effective to each patient based on their individual genetic makeup.
Northstar ResponseTM will enable clinicians to monitor a patient's early response to these cancer therapies, by measuring minute changes in their ctDNA, which can reduce ineffective treatments and unwanted toxicity, lower costs, and substantially improve clinical outcomes.
As the Sr.Quality Engineer, you will have a strong background in the LDT environment, with expertise in lab practices, bioinformatics, report automation, assays, and reagents.
Additionally, you will possess a deep understanding of quality tools and practices to ensure the highest standards of our products and services.
In this role you will be responsible for identifying, developing, and executing process improvements and will work closely with cross-functional stakeholders across BillionToOne (e.g. Lab Operations, R&D, Bioinformatics, Software Engineering).You will lead the analysis of data to identify improvement initiatives and will execute those process improvements from initial requirements gathering to go-live and further continuous improvement.
This role is an onsite position in our brand new, state-of-the-art, 90,000 square foot facility in Union City, CA and will report directly to the Vice President of QARA.
Responsibilities:
Perform statistical analysis and trending of quality data to identify improvement opportunities and monitor the effectiveness of quality initiatives.
Conduct root cause analysis and implement corrective and preventive actions (CAPA) to address non-conformances and drive continuous improvement.
Collaborate with cross-functional teams, including laboratory operations, bioinformatics, software engineering, and assay development, to identify and implement improvements.
Develop and maintain quality documentation, including SOPs, validation protocols, and quality reports.
Provide training and guidance to team members on quality tools, practices, and regulatory requirements.
Develop, implement, and maintain quality systems and processes in compliance with regulatory requirements for LDTs.
Stay current with industry trends, regulations, and best practices related to LDTs and molecular diagnostics.
Requirements:
Bachelor's degree in a scientific or technical field (e.g., biology, chemistry, biomedical engineering, manufacturing or related discipline); advanced degree preferredMinimum of 5 years of experience within the LDT industry and familiarity with relevant regulations and guidelines, such as CLIA, CAP, and state-specific requirements for LDTsStrong knowledge of lab practices, bioinformatics, report automation, assays, and reagentsExpertise in quality tools and practices, including root cause analysis, CAPA, and statistical analysisExperience with quality management systems and continuous improvement methodologies (e.g.
Ability to work independently and cross-functionally to implement systems and processesCreative problem solving, detail oriented, and critical thinker characteristics requiredProven ability to drive results to established timelinesProven ability to communicate effectively both in writing and verballyMust be comfortable and effective acting as a catalyst for change Nice-To-Haves:
Experience with ISO13485 and FDA CFR a plus
Benefits And Perks:
Working with a team of 'rockstars' who bring out the best in everyoneOpen, transparent culture that includes weekly Town Hall meetingsThe ability to indirectly or directly change the lives of hundreds of thousands patientsMultiple medical benefit options; employee premiums paid 100% of select plans, dependents covered at 80%Extremely generous Family Bonding Leave for new parents (16 weeks, paid at 100%)Retirement savings program including a 4% Company matchFree daily on-site lunches provided from top eateriesLatest and greatest hardware (laptop, lab equipment, facilities)A variety of perks on campus (state of the art gym, restaurant)Free on-site EV charging (compatible with all EVs, including Tesla)At BillionToOne, we are proud to offer a combination of a (1) base pay range (actual amount offered is based experience and salary/equity options split that the candidate chooses) (2) generous equity options offering, on top of (3) industry leading company benefits (free healthcare options, 401k match, very generous fully paid parental leave etc.).For this position, we offer a base pay range of $150,000-$175,000 per year.
BillionToOne is an equal opportunity employer.We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
