ISO 13485 jobs in Calabasas, CA

Thousand Oaks, California

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Today

Job Description: The Product Development Engineer is engaged in executing the main elements of New Product Development to introduce surgical implants, prosthetics, and instruments to market. In this role, you will participate in the following: Concept Development, Design & Development, Design Verification & Validation, and Design Transfer to production. You will serve as a core team member of the Design Engineering team, while partnering with cross-functional experts on projects. You will parti

Full-time

USD 98,700.00 - 120,700.00 per year

Senior Engineer, QA Engineering (MQ) - Onsite

Calabasas, California

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Today

The Senior Engineer, Quality Engineering (Manufacturing Quality) is responsible for leading QC operations while providing Quality Engineering support for manufacturing. The role ensures product quality, regulatory compliance, effective quality systems, and continuous improvement through leadership of quality inspections, investigations, NPI activities, manufacturing quality initiatives, and cross-functional collaboration. (On-site) Let's talk about Responsibilities Lead and manage Quality Contr

Full-time

USD 122,000.00 - 184,000.00 per year

Senior Engineer, Electrical Test - ATE (Valencia (CA), United States)

Santa Clarita, California

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Today

Valencia, CA - Onsite Senior Engineer, Electrical Test - ATE The Senior Electrical Test Engineer, in the role of Senior Professional Test and Verification Engineering, performs complex assignments of the engineering test and verification function for hearing systems. The Senior Electrical Test Engineer is responsible for the design and specification and construction of automated test equipment (ATE) to verify the design and the manufacturing of Medical Class systems, consisting of active impl

Full-time

USD 100,320.00 per year

Senior Moulding Engineer (Onsite)

Calabasas, California

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Today

The Senior Moulding Engineer owns scientific molding process development and qualification for thermoplastic, LSR, and over molding programs. Independently develops, defends, and releases molding processes to standard, and raises the molding capability of less-experienced engineers. This is the team's independent technical owner of the molding process - the person whose signature on a molding qualification means the process is sound. Scope and accountability Owns complex, multi-cavity and multi-

Full-time

USD 117,000.00 - 175,000.00 per year

Quality Assurance Engineer

Torrance, California

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Today

Quality Assurance Engineer Torrance, CA Full-Time | On-Site Salary: $100,000-$125,000 An established technology company specializing in professional fiber transmission solutions is seeking an experienced Quality Assurance Engineer to support the quality and reliability of video and audio products. This role will work closely with Engineering and Production teams to perform testing, troubleshooting, process improvement, documentation, and quality compliance activities. Responsibilities include

Full-time

USD 100,000.00 - 125,000.00 per year

Auditor

Remote or Chicago, Illinois

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Yesterday

Job Title: Quality Auditor Locations: Remote (50 - 60% Travel is expected anywhere in US but that will be sponsored) Duration: 6 months Contract Pay Range: $40 - $43/hr. Must Have's 8+ years of Quality Assurance and Quality Auditing experience within the medical device or pharmaceutical industry Extensive experience leading supplier/vendor audits from planning through final reporting Expert knowledge of FDA regulations (21 CFR Parts 210, 211, and 803), ISO 13485, and Quality Management Systems

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Full-time

$40.0000 - $43.0000

Engineer, Combination Devices (Technical Lead)

Pasadena, California

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Today

Arrowhead Pharmaceuticals, Inc. (Nasdaq ARWR) is a commercial stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene

Full-time

USD 120,000.00 - 145,000.00 per year

Senior Engineer, Design Assurance (Valencia (CA), United States)

Santa Clarita, California

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Today

Valencia, CA - Hybrid (3 days/week on site, 2 days remote) Senior Engineer, Design Assurance The Senior Design Assurance Engineer is responsible for compliance to procedures and regulations for Design Control of Software, Firmware and Hardware associated with Cochlear Implant Technology. Works collaboratively as the DA representative within a multidisciplinary product development team to ensure the design intent of products is realized effectively and efficiently, including compliance with 21CF

Full-time

USD 100,320.00 - 150,480.00 per year

Backend AI Engineer - Remote

Remote or San Diego, California

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Today

Genesis10 is currently seeking a Backend AI Engineer - Remote for a contract position with a Global Medical Technology Company located in San Diego, CA. This is a 12+ month contract opportunity. This position is 100% remote. Compensation: $43.00 - $53.00 per hour, W2, based on qualifications Position Overview: This role focuses on developing and implementing generative AI solutions, including building robust RAG pipelines, fine-tuning LLMs, and creating high-performance APIs. The ideal candidat

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Full-time

Compensation information provided in the description

Senior Staff Software Advance Quality Engineer

Remote or Detroit, Michigan

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Today

Work Flexibility: Remote or Hybrid or Onsite It's Time to Join Stryker! Why Join Us In this role, you will help shape software quality practices across a growing portfolio of digital and connected solutions. You will influence how software teams incorporate quality, compliance, security, and risk management into development while establishing scalable processes that support innovation and efficient delivery. Stryker is seeking a Senior Staff Software Quality Assurance Engineer to support our

Full-time

USD 102,600.00 - 171,000.00 per year

Staff Software Engineer

Remote or California

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Today

The Opportunity QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers with fast, accurate and consistent testing where and when they are needed most - home to hospital, lab to clinic. Our culture puts our team me

Full-time

USD 140,000.00 - 160,000.00 per year

Senior Account Manager- Medical Devices

Remote

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Today

Req ID: 137305 Remote Position: Yes Region: Americas Country: USA Summary Celestica is dedicated to delivering end-to-end product lifecycle solutions to drive our customers' success. Our growing Advanced Technology Solutions (ATS) organization focuses on applying Celestica's advanced capabilities, knowledgeable people and innovative tools to enable companies in the medical device industry with highly complex, mission critical applications to improve their competitive advantage. We are current

Full-time

USD 123,000.00 - 163,000.00 per year

Principal Engineer, Customer Quality

Remote

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Today

Littelfuse (NASDAQ: LFUS) is a diversified industrial technology manufacturing company shaping solutions for the safe and efficient transfer of electrical energy. Headquartered in Chicago, Illinois, USA, we serve customers across industrial, transportation, and electronics markets worldwide. With approximately 16,000 employees we design and manufacture innovative technologies that support electrification, energy efficiency, and advanced automation. Our global reach is matched by a culture that e

Full-time

USD 123,100.00 - 190,780.00 per year

Senior Database Design Engineer

Remote

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Today

Full-time

USD 100,000.00 - 120,000.00 per year

Principal HL7 Integration Engineer

Remote

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Today

Position Overview The Principal HL7 Integration Engineer oversees all technical aspects of Synapse product HL7 integration, from install, configure and validation phases through product go-live, for all Synapse MI products. The Principal HL7 Integration Engineer must have expert level knowledge in all areas of medical informatics, IT infrastructure design and deployment, medical imaging industry in general and clinical environment workflow. In addition to technical expertise, HCUS relies on Th

Full-time

USD 110,366.00 - 140,000.00 per year

Medical Device V&V engineers

Remote or New Jersey

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Today

Summary: We are seeking highly skilled and experienced System Engineers to join our team. The ideal candidate will have 5-8 years of experience in the medical device industry, with a strong focus on Design Controls, traceability, and design validation. This individual will play a critical role in ensuring that user needs are clearly traced to design inputs, verification, and validation throughout the product development lifecycle. Roles & Responsibilities: Design Controls: Lead efforts to deve

Full-time

Process Development Engineer

Hawthorne, California

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Today

SpaceX was founded under the belief that a future where humanity is out exploring the stars is fundamentally more exciting than one where we are not. Today SpaceX is actively developing the technologies to make this possible, with the ultimate goal of enabling human life on Mars. PROCESS DEVELOPMENT ENGINEER - BUILD RELIABILITY The Process Development Engineer is responsible for developing and improving business processes and systems that enable SpaceX to design, build, launch, and reuse the m

Full-time

USD 100,000.00 - 115,000.00 per year

Process Validation Engineer

Los Angeles, California

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2d ago

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,

Easy Apply

Third Party, Contract

$60+

Senior Software Design Assurance (Sr Software Design Quality) Engineer

Remote

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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

Engineer I, Software Quality

Remote

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Today

Position Overview This position is intended to be an entry level position focused on software functional testing and quality assurance, and the fulfillment of relevant procedure and documentation per Fujifilm Medical Informatics Design Control process for software development. Company Overview At FUJIFILM Healthcare Americas Corporation, we're on a mission to innovate for a healthier world, and we need passionate, driven people like you to help us get there. Our cutting-edge healthcare soluti

Full-time

ISO 13485 jobs in Calabasas, CA, USA