21 cfr part 820 jobs in california

Sunnyvale, California

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2d ago

Description: Position Overview The Supplier Engineer is responsible for ensuring suppliers reliably support plant production by meeting Intuitive requirements for quality, delivery, capacity, cost, and service. This role is highly execution-focused and serves as the primary technical interface between the plant and suppliers to resolve line-impacting issues, improve supplier manufacturing processes, and maintain stable production operations across multiple product families. The Supplier

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Contract, Third Party

$60 - $75

Validation Engineer

San Jose, California

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Today

Summary: In this position, you will be responsible for the planning, execution, and documentation of validation protocols (IQ/OQ/PQ) for medical device manufacturing processes and equipment. You will work cross-functionally to ensure the products meet the highest quality standards. Roles & Responsibilities: Develop and execute validation plans and reports. Analyze data and troubleshoot process deviations. Ensure compliance with FDA regulations and ISO standards. Collaborate with Engineering an

Full-time

process validation engineer

Los Angeles, California

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Today

Key Responsibilities Develop and execute IQ/OQ/PQ protocols for critical manufacturing processes.Conduct process characterization using DOE, SPC, and statistical modeling.Perform process capability studies (Cp/Cpk) and implement corrective actions for lowcapability processes.Define and maintain the Process Validation Master Plan (PVMP).Prepare validation protocols, reports, risk assessments, PFMEAs, and process maps.Support pilottoproduction scaleup for new blood glucose sensor manufacturing lin

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Contract

Depends on Experience

Process Validation Engineer

Los Angeles, California

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Today

Position: Process Validation EngineerLocation: Northridge, CA-On SiteDuration: 12+ Months Contract Key ResponsibilitiesDevelop and execute IQ/OQ/PQ protocols for critical manufacturing processes.Conduct process characterization using DOE, SPC, and statistical modeling.Perform process capability studies (Cp/Cpk) and implement corrective actions for lowcapability processes.Define and maintain the Process Validation Master Plan (PVMP).Prepare validation protocols, reports, risk assessments, PFMEAs,

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Contract, Third Party

$60+

Component Engineer

Irvine, California

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Today

Responsibilities: DVT & Design Release Support. Participate in DVT readiness and design reviews to identify component risks, manufacturability concerns, and documentation gaps. Support design transfer activities to ensure readiness for manufacturing release. Component Risk & Lifecycle Assessment Evaluate lifecycle status (NRND/EOL), supplier risk, and availability Recommend alternates and mitigation strategies. Support Release of OTS and custom parts Mechanical Drawing Review & Manufacturability

Full-time

Engineer III, Design Quality (Hybrid - San Clemente, CA)

San Clemente, California

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Today

Job Description Position Summary Provide quality support for ICU Medical Consumable development. The Quality Engineer will support activities such as CAPA investigations, design projects, and will ensure compliance with ICU Medical quality system requirements and applicable regulations and standards, such as ISO 13485, ISO 14971, 21 CFR Part 820, and other applicable regulations and standards. Essential Duties & Responsibilities Effectively utilize quality tools and processes such as product

Full-time

USD 90,000.00 - 129,000.00 per year

Bioinformatics Pipeline Junior Test Engineer

San Diego, California

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Today

Requirements: B.S. Degree in Computational Biology, Computer Science, or field as outlined in the essential duties. Familiarity with the development of bioinformatics pipelines within Next Generation Sequencing and PCR applications. Familiarity with production software development lifecycle. Familiarity with best practices for software development (such as Git, agile, code reviews, CI/CD). bility to effectively communicate software system designs. Excellent communication skills (both written and

Full-time

Staff NPI Process Quality Engineer

San Diego, California

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Today

As a result of the combination of the BD Biosciences and Diagnostic Solutions business with Waters Corporation (NYSE: WAT), by applying to this role, you will be applying for a position with Waters. Waters is a global leader in life sciences, dedicated to accelerating the benefits of pioneering science through analytical technologies, informatics, and service. With a focus on regulated, high-volume testing environments, Waters' innovative portfolio harnesses deep scientific expertise across biol

Full-time

USD 129,600.00 - 207,400.00 per year

Supplier Engineer 3 - Plastics

San Diego, California

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Today

Job Description Hologic is one of the world's most innovative medical technology companies and a global champion of women's health. We advance diagnostic, detection, and surgical solutions that respond to an increasingly complex and demanding global healthcare environment. What powers our growth is also what differentiates us: the exceptional, clinically proven ability of our products to detect, diagnose, and treat illnesses and other health conditions earlier and better. Our commitment to bet

Full-time

USD 97,000.00 - 140,000.00 per year

Sr Software QA Engineer

San Diego, California

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Today

The Company Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Dexcom began as a small company with a big dream: To forever change how diabetes is managed. To unlock information and insights that drive better health outcomes. Here we are 25 years later, having pioneered an industry. And we're just getting started. We are broadening our vision beyond diabetes to empower people to take control of health. That means personalized, actionable insig

Full-time

USD 95,900.00 - 159,900.00 per year

Hardware Engineer 2

San Diego, California

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Today

Full-time

USD 91,400.00 - 152,300.00 per year

Senior Test Engineer

San Francisco, California

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Today

Heartflow is a medical technology company advancing the diagnosis and management of coronary artery disease, the #1 cause of death worldwide, using cutting-edge technology. The flagship product-an AI-driven, non-invasive cardiac test supported by the ACC/AHA Chest Pain Guidelines called the Heartflow FFRCT Analysis-provides a color-coded, 3D model of a patient's coronary arteries indicating the impact blockages have on blood flow to the heart. Heartflow is the first AI-driven non-invasive integr

Full-time

USD 165,000.00 - 205,000.00 per year

Process Development Engineer IV (Staff)

San Diego, California

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Today

Job Type Full-time Description WARNING about fake job posting scams. There has been a recent wave of scams whereby third parties post fake job openings using a bogus email address that resembles Under the guise of asking you to fill out an application, the scammers are attempting to gather your personal information. See the Federal Trade Commission's warning on this topic at: The only official source for actual Biolinq job postings/openings is at . While other job sites (such as LinkedIn, In

Full-time

USD 130,000.00 - 145,000.00 per year

Supplier Industrialization Engineer

South San Francisco, California

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Today

About Neuralink: We are creating devices that enable a bi-directional interface with the brain. These devices allow us to restore movement to the paralyzed, restore sight to the blind, and revolutionize how humans interact with their digital world. About the Team Supply Chain owns the external manufacturing network that builds and delivers every component going into the Implant and the Robot. The Supplier Industrialization Engineering (SIE) function partners with Design, Quality, Manufacturin

Full-time

USD 68,000.00 per year

Cybersecurity Quality Engineer

Irvine, California

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Today

Job Description Job Summary: The Cybersecurity Quality Engineer supports the integration of cybersecurity requirements into the product development lifecycle and quality management system for Masimo medical device products. Working under the guidance of senior quality, software, and cybersecurity team members, this role assists in ensuring cybersecurity-related activities are documented, traceable, and executed in accordance with applicable regulatory requirements, quality system procedures, a

Full-time

USD 85,000.00 - 105,000.00 per year

Software Quality Engineer II

Irvine, California

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Today

Job Description Job Summary The Software Quality Engineer II supports the development and lifecycle management of software used in medical devices by ensuring quality, compliance, and effective risk management throughout the product lifecycle. This role partners closely with Software Engineering, Systems Engineering, Regulatory Affairs, and Product Development teams to provide quality oversight from concept through commercialization. The Software Quality Engineer II is responsible for reviewi

Full-time

USD 75,000.00 - 100,000.00 per year

Senior Manager, R&D Software Engineering

Milpitas, California

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Today

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn m

Full-time

USD 157,000.00 - 271,400.00 per year

Principal AI Quality Engineer

Vista, California

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Today

Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Leica Biosystems, one of Danaher's 15+ operating companies, our work saves lives-and we're all united by a shared commitment to innovate for tangible impact. You'll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher's system of continuous improvement, you help turn ideas into impact - innovating at

Full-time

USD 160,000.00 - 180,000.00 per year

Senior Software Design Assurance (Sr Software Design Quality) Engineer

Remote

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Today

Full-time

USD 95,900.00 - 159,900.00 per year

Staff Software Engineer

San Jose, California

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Today

Work Flexibility: Hybrid or Onsite Stryker is seeking a Staff Software Engineer to join our Endoscopy division. This role will lead the design and development of Windows-based software applications supporting our Connected OR platform, with a strong focus on C#, .NET, Windows Presentation Foundation (WPF), hardware integration, and communication between connected medical devices and systems. The ideal candidate brings deep experience developing desktop applications and software architectures in

Full-time

USD 133,400.00 - 222,300.00 per year

21 cfr part 820 jobs in California, USA