- 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.
- A scientific or engineering degree relevant to 10x's technologies and processes (e.g., computer/electrical, materials science, mechanical, optical)
- 8 years' experience in automotive, life science or medical device manufacturing, and/or semiconductor industries with direct experience in electrical, mechanical, optics, and related supplier management.
- Experience with quality and statistical analysis tools (e.g. 5 Why, 8D, A3, Fishbone/Ishikawa, 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.
- Proficient with ASME Y14.5 GD&T, ISO GPS, or equivalent
- Experience with ISO9001
- Ability to travel up to 25%
- Advanced degree.
- Hands-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
1 week 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
1 week 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 Engineer II
6 days 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
4 days 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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Sr. Quality Engineer
1 week 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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Senior Quality Engineer
3 days 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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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
1 week 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, analyzing and r ...
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Senior Quality Engineer
1 week 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 III
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Clinch Pleasanton, United StatesBe part of the digital biology revolution... · Bio-Rad is a leader in the development of innovative droplet digital PCR systems. Bio-Rad's QX200 ddPCR system represents a new era in reliability and affordability across a range of applications for life science researchers and mol ...
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AbbVie Dublin, United StatesJob Description · The full job description covers all associated skills, previous experience, and any qualifications that applicants are expected to have. · Key Responsibilities · Support the development of medical devices and/or device components of combination products by prov ...
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Quality Engineer
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AbbVie Dublin, United StatesJob Description · Key Responsibilities · Support the development of medical devices and/or device components of combination products by providing support on applicable design control, human factors/usability engineering, and risk management processes. · Support implementation of ...
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BioSpace, Inc. Dublin, United StatesJob Details · Company Description · AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key t ...
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Actalent San Mateo, United States Full timeDescription: · • Act as a quality engineer for medical device QMS quality improvement activities, with a focus on design controls and risk management. · • Provide oversight of quality improvement activities and ensure compliance with FDA 21 CFR Part 820, 21 CFR Part 4, ISO 13485, ...
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Senior Cybersecurity Quality Engineer
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Senior Cybersecurity Quality Engineer
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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 ...
Senior Quality Engineer - Pleasanton, United States - 10X Genomics
Description
10x 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 discoveries and drive progress to master biology to advance human health.
Responsibilities:
Minimum Qualifications:
Preferred Qualifications:
#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 $131,000—$177,000 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.
Senior Quality Engineer professionals in Pleasanton
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Arun Voleti
Director of Engineering
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David Vieler
Cross-functional resource that delivers.