- Support product quality and manufacturing activities and are accountable for driving change, establishing effective and sustainable business processes (nonconformity, customer complaints and CAPA), improving product quality, and providing senior management with actionable data mining/analysis and status updates.
- Provide quality support for NPI activities including process and product transfer, and QC method validation, equipment and process qualification and facility validation, and product lifecycle management, as well as ongoing sustaining operations.
- Manages the execution of objectives for the control of internal and external suppliers and contract manufacturers to assure the supply of acceptable quality of materials and product, resolve supplier quality issues and monitor supplier quality performance, and maintains associated metrics (NCs, Audits, Audit Actions, SCARs).
- Aides in the assessment and qualification of new supplier materials such as raw materials, component specifications and inspection standards. Identify opportunities for reduced inspection of purchased materials based on risk and quality performance.
- Understand the applicable 10x technologies to participation in technical discussions, drive and facilitate product design and process risk management activities and coordinate issue resolution.
- Ensure that corporate business practices are compliant with IS09001:2015, ISO13485, FDA 21 CFR part 820.
- A scientific or engineering degree relevant to 10x's technologies and processes.
- 8 years' experience in life science or medical device manufacturing with direct experience in instrument, chemical, biological, and related supplier management.
- Experience with quality and statistical analysis tools (e.g. Risk Analysis, FMEA, DOE, SPC, Six Sigma)
- Direct experience supporting development and commercial quality systems in a Quality Assurance and/or Quality Engineering role.
- Practical experience in product quality management, quality and process improvement methodologies, failure investigation tools and techniques.
- Strong understanding and practice experience with product development and transfer (risk management, validation, NPI) and sustaining (change controls, CAPA).
- Strong collaboration and communication skills with colleagues and external collaborators.
- Experience with ISO9001
- Ability to travel up to 25%
- Advanced degree preferred.
- Hand on experience with electronic PLM, ERP, MES and enterprise Quality System tools.
- Quality certification desirable (e.g. CQM, CQE, CQA, RAC).
- Experience with ISO 13485, and FDA 21 CFR part 820 quality systems in a Quality Assurance/Quality Engineering role.
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Quality Engineer
3 weeks ago
Katalyst Healthcares and Life Sciences Pleasanton, United StatesResponsibilities: Participate in design reviews, Risk Management, Validation & Verification plans and reports during Product Development as required. Responsible for Design Transfer activities for new product introductions internally or externally, ensuring quality and manufactur ...
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Quality Engineer
3 weeks ago
Katalyst Healthcares and Life Sciences Pleasanton, United StatesResponsibilities: Should be able to handle stress and pressure at times 8+ years of quality engineering and/or operations experience including a minimum 5 years' experience in an electro-mechanical, assembly and test manufacturing environment. Team player Design Control and/or De ...
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Quality Engineering Manager
4 days ago
Penumbra Alameda, United States**What You'll Work On**: · - As a leader, manage the quality engineering functions in support of production to ensure conformance to the Penumbra Quality Management System, FDA QSR, ISO standards, and other regulatory requirements within a multidisciplinary team · - Direct manage ...
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Quality Engineering Technician
1 week ago
Joby Aviation San Carlos, United StatesJoby Overview: Located in Northern California, the Joby Aviation team is steadily working toward our goal of creating an affordable, all-electric air transportation system. Imagine an air taxi that takes off vertically, then quietly and quickly carries you over the traffic conges ...
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Senior Quality Engineer
1 week ago
10X Genomics Pleasanton, United States Freelance10x Genomics is seeking a Senior Quality Engineer, who will be a member of the Global Quality organization. In this role, you will leverage your engineering skills and make meaningful contributions toward the the development of cutting edge-instruments that enable scientific disc ...
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Senior Quality Engineer
3 weeks ago
10X Genomics Pleasanton, United States10x is seeking a · Senior Quality Engineer, · who will be a member of the · Global Quality organization , reporting to the Senior Director of Global Quality and Document Control. In this cross functional quality role, you will be responsible for identifying, documenting, analy ...
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Quality Engineer II
2 weeks ago
Hitachi Data Systems Pleasanton, United StatesLocation: PLEASANTON,California,United States · Job ID: · R0051001 · Date Posted: · May 7, 2024 · Segment: · Others (Including Headquarters and R&D ) · Business Unit: · Hitachi Regional Headquarters · Company Name: · HITACHI AMERICA, LTD. · Profession (Job Category): · Engi ...
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Senior Quality Engineer
3 weeks ago
10X Genomics Pleasanton, United States10x Genomics is seeking a Senior Quality Engineer, who will be a member of the Global Quality organization. In this role, you will leverage your engineering skills and make meaningful contributions toward the the development of cutting edge-instruments that enable scientific disc ...
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Senior Quality Engineer
2 weeks ago
10X Genomics Pleasanton, United States Freelance10x Genomics is seeking a Senior Quality Engineer, who will be a member of the Global Quality organization. In this role, you will leverage your engineering skills and make meaningful contributions toward the the development of cutting edge-instruments that enable scientific disc ...
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Senior Quality Engineer
3 weeks ago
10X Genomics Pleasanton, United States Freelance10x Genomics is seeking a Senior Quality Engineer, who will be a member of the Global Quality organization. In this role, you will leverage your engineering skills and make meaningful contributions toward the the development of cutting edge-instruments that enable scientific disc ...
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Engineer II, Quality
1 week ago
Abbott Pleasanton, United StatesAbbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medic ...
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Sr. Quality Engineer
3 weeks ago
Katalyst Healthcares and Life Sciences Pleasanton, United StatesResponsibilities: Participate in design reviews, Risk Management, Validation & Verification plans and reports during Product Development as required. · Responsible for Design Transfer activities for new product introductions internally or externally, ensuring quality and manufac ...
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Engineer II, Quality
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Abbott Pleasanton, United StatesAbbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medic ...
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Senior Quality Engineer
2 weeks ago
10X Genomics Pleasanton, United States10x is seeking a · Senior Quality Engineer, · who will be a member of the · Global Quality organization , reporting to the Senior Director of Global Quality and Document Control. In this cross functional quality role, you will be responsible for identifying, documenting, analy ...
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Engineer II, Quality
1 week ago
Abbott Laboratories company Pleasanton, United StatesAbbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medic ...
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Engineer II, Quality
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Abbott Laboratories company Pleasanton, United StatesAbbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medic ...
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Quality Assurance Engineer
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Penn Foster Inc Pleasanton, United StatesYour work days are brighter here. · At Workday, it all began with a conversation over breakfast. When our founders met at a sunny California diner, they came up with an idea to revolutionize the enterprise software market. And when we began to rise, one thing that really set us ...
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Engineer II, Quality
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Lead Quality Engineer
1 week ago
Nisum Pleasanton, United StatesNisum is a leading global digital commerce firm headquartered in California, with services spanning digital strategy and transformation, insights and analytics, blockchain, business agility, and custom software development. Founded in 2000 with the customer-centric motto "Buildin ...
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Lead Quality Engineer
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Nisum Pleasanton, United StatesNisum is a leading global digital commerce firm headquartered in California, with services spanning digital strategy and transformation, insights and analytics, blockchain, business agility, and custom software development. Founded in 2000 with the customer-centric motto " · Bui ...
Senior Quality Engineer - Pleasanton, United States - 10X Genomics
Description
10x is seeking a Senior Quality Engineer, who will be a member of the Global Quality organization, reporting to the Senior Director of Global Quality and Document Control. In this cross functional quality role, you will be responsible for identifying, documenting, analyzing and reporting product quality issues, CAPA and NCs appropriately evaluated and resolved. You will ensure product and process conformance to applicable quality system requirements and standards. Also, you will be responsible to ensure that business processes across the company are compliant with ISO9001,ISO13485, and FDA 21 CFR part 820 Standards.
What you will be doing:
Minimum Qualifications:
Preferred skills:
#LI-ES1 #LI-onsite #qualityengineerjobs
Below is the base pay range for this full time position. The actual base pay will depend on several factors unique to each candidate, including one's skills, qualifications, and experience. At 10x, base pay is also just one component of the Company's total compensation package. This role is also eligible for 10x's equity grants, its comprehensive health and retirement benefit programs, and its annual bonus program or sales incentive program. Your 10x recruiter can share more about the Company's total compensation package during the hiring process.
Pay Range
$133,200—$162,800 USDAbout 10x Genomics
At 10x Genomics, accelerating our understanding of biology is more than a mission for us. It is a commitment. This is the century of biology, and the breakthroughs we make now have the potential to change the world.
We enable scientists to advance their research, allowing them to address scientific questions they did not even know they could ask. Our tools have enabled fundamental discoveries across biology including cancer, immunology, and neuroscience.
Our teams are empowered and encouraged to follow their passions, pursue new ideas, and perform at their best in an inclusive and dynamic environment. We know that behind every scientific breakthrough, there is a deep infrastructure of talented people driving the life sciences industry and making it possible for scientists and clinicians to make new strides. We are dedicated to finding the very best person for every aspect of our work because the innovations and discoveries that we enable together will lead to better technologies, better treatments, and a better future. Find out how you can make a 10x difference.
Individuals seeking employment at 10x Genomics are considered without regards to race, color, religion, national origin, age, sex, marital status, ancestry, physical or mental disability, veteran status, gender identity, or sexual orientation, or any other characteristic protected by applicable law.
10x does not accept unsolicited applicants submitted by third-party recruiters or agencies. Any resume or application submitted to 10x without a vendor agreement in place will be considered unsolicited and property of 10x, and 10x will not pay a placement fee.
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