Quality Engineer
Katalyst Healthcares and Life Sciences
Summary
We are looking for a Quality Engineer with 0-3 years of experience to support quality systems, validation, CAPA, and compliance activities in a regulated medical device/pharma environment. The role involves working closely with cross-functional teams to ensure product quality and regulatory compliance.
Roles & Responsibilities:
We are looking for a Quality Engineer with 0-3 years of experience to support quality systems, validation, CAPA, and compliance activities in a regulated medical device/pharma environment. The role involves working closely with cross-functional teams to ensure product quality and regulatory compliance.
Roles & Responsibilities:
- Support equipment, process, and software validation (CSV, IQ/OQ/PQ).
- Assist with CAPA, non-conformance (Client/MRB), and root cause investigations.
- Maintain quality documentation and analyze quality metrics.
- Support internal/external audits and ensure compliance with FDA, ISO 13485, and GMP requirements.
- Collaborate with Engineering, Manufacturing, and R&D on quality initiatives.
- Bachelor's degree in Engineering, Biomedical Engineering, or a related field.
- 0-3 years of experience in Medical Devices, Pharma, Biotech, or other regulated manufacturing environments.
- Basic knowledge of FDA 21 CFR 820, ISO 13485, CAPA, Validation, and Quality Management Systems.
- Strong analytical, documentation, and communication skills.
- Exposure to CSV, IQ/OQ/PQ, ISO 14971, GMP, or cleanroom environments.
Vacancy posted 13 hours ago
Similar jobs that could be interesting for youBased on the Quality Engineer in Pleasanton, CA vacancy
- Job-ID32276842Reference26-00617 Roles & Responsibilities: 5 to 6 years of Medical Device Supplier Quality experience with Electrical background. Candidates with IPC certifications & Expertise in PCBA inspections. Experience in Interacting with US & Overseas supplier Experience...SuggestedOverseas
$136.2k - $178.82k
...matter.Shift:The regular hours for this position are day shift.Job Description:FormFactor is seeking a Senior Principal Quality Assurance Engineer to lead key elements of our enterprise Quality Management System (QMS) and drive continuous improvement across global operations...SuggestedFull timeLive inLocal areaRemote workFlexible hoursShift workDay shift- ...include, but are not limited to: Debug software products through the use of systematic tests to develop, apply, and maintain quality standards for company products Develop an automation roadmap and helps initiate the right framework and maintain the existing automation...SuggestedLocal areaRemote workRelocation
Software Technology Inc
Pleasanton, CA3 days ago - Job Title Skills Matrix - Years of experience - Proficiency (Beginner, Intermediate or advanced) Android Studio - ADB tool Xcode - XUITest Appium + any programming language Espresso Charles proxy Postman Emulator SimulatorSuggested
Netpace
Pleasanton, CA3 days ago - ...Quality Engineer We are looking for a Quality Engineer with 0–3 years of experience to support quality systems, validation, CAPA, and compliance activities in a regulated medical device/pharma environment. The role involves working closely with cross-functional teams...Suggested
Katalyst HealthCares & Life Sciences
Pleasanton, CA1 day ago $75k - $85k
...Job Duties First Article Inspection and Approvals CCB – Engineering Change Control Board – Leads and facilitates the Change Control... ...products, manufacturing processes, systems, documentation, quality, cost, and delivery timelines RFD – Request for Deviation -...Full timeTemporary workTopcon Positioning Systems Inc
Livermore, CA3 days ago- ...Quality Engineer I Job title: Quality Engineer I Location: Pleasanton, CA Duration: 7+ months (Possibility of extension) JOB ROLES: The Quality Analyst – Post Market Vigilance will review, evaluate, and investigate product complaints relative to the identity...
Integrated Resources
Pleasanton, CA23 hours ago $150k - $180k
...Senior Quality Engineer Noctrix Health is redefining the treatment of chronic neurological disorders with clinically validated therapeutic wearables. Our team of medical device specialists, neuroscientists, and consumer electronics engineers is dedicated to delivering...Full timeContract workNoctrix Health
Pleasanton, CA12 hours ago$132.8k - $179.6k
...biological systems at a resolution that matches the complexity of biology. We are seeking a highly experienced and motivated Senior Quality Engineer to join our team and drive excellence in supplier quality. What you will be doing Supporting the selection of new...Full time10X Genomics
Pleasanton, CA1 day ago- Join to apply for the SR SOFTWARE QUALITY ENGINEER role at Noetic Information Systems LLC SR SOFTWARE QUALITY ENGINEER responsibilities include: Monitor phases of IT engagement including business process initiation, problem definition, discovery, solution generation, design...Remote workRelocation
- Overview SR. QUALITY ENGINEER. Master’s degree in Computer Science, Information Studies with 1 year experience in a job title with similar duties and skills. Responsibilities Maintain data related technologies including relational databases (SQL Server, PostgreSQL, etc...Remote workRelocation
- ...SR. SOFTWARE QA ENGINEER Noetic Information Systems LLC Phone: (***) ***-**** / (***) ***-**** Email: ****@*****.*** Address: 5776 Stoneridge Mall Road, Suite 255, Pleasanton, CA 94588 Master’s degree in Information Technology, Computer Science with 2 years of...Remote workRelocation
Noetic Information Systems LLC
Pleasanton, CA2 days ago - Teleflex is seeking a Quality Engineer III, Design Assurance to lead quality activities across new product development through commercialization. You will collaborate with R&D, Regulatory, Marketing and Operations to ensure design verification/validation, risk management...
$101k - $125k
...business partners, and employees achieve success through shared goals, strategies, resources and technology solutions.The Test Quality Engineer is responsible for ensuring the effectiveness, reliability, and compliance of product testing processes throughout the...Full time$115.3k - $130k
...technologies, Teleflex is driven by our purpose to improve the health and quality of people’s lives. Through our vision to become the most... ...Summary As a member of a cross-functional team, the Quality Engineer III, Design Assurance is responsible for quality throughout new...Temporary workLocal areaFlexible hours- ...Quality Assurance Professional We are seeking a detail-oriented and experienced Quality Assurance (QA) professional to join our direct client. The successful candidate will be responsible for the validation and verification of enterprise resource planning (ERP) and...
Kasmo Global
Fremont, CA3 days ago $81k - $141k
...: The top priorities of this position will be to support Quality and ISO 9001 in all areas of the IEM Organization at manufacturing... ...(Six Sigma, SPC, GRR, 5Y, CAR, etc.) Working with Engineering team on continuous improvement opportunities Knowledge of IPC...Work at officeUS - Industrial Electric Manufacturing
Fremont, CA23 hours ago- Job DescriptionJob DescriptionOn-SEM-Site Supplier Quality Engineer providing a collaborative environment for SEM including: Collaborate with production supervisors and workers for real-time inspection and verification points during processing.Drive closure with AIS stakeholders...
- ...worldwide. Innovations from Mattson Technology in Atomic Surface Engineering address the most critical logic and memory manufacturing... ...serving customers outside of China.About the RoleThe Supplier Quality Engineer role plans, develops and executes on the introduction...Work at officeWorldwide
$114k - $228k
...executives, and scientists.The Opportunity Main Purpose: Independently or lead a project team of supervisors/engineers/technicians, to support Design/ Development Quality. Identify, plan and conduct projects requiring a combination of conventional and custom risk-managed...Work experience placementWorldwideShift work$110k - $140k
...provides end-to-end manufacturing solutions, delivering superior quality and support to Original Equipment Manufacturers (OEMs)... ...has morphed into an era of robotics, automation, and complex engineering. Fremont supports the critical infrastructure driving the semiconductor...Permanent employmentWork experience placementFlexible hours$116k - $126k
...to our customers. We are currently looking for a Marketing QA Engineer II to join our Tailored Technology team. In this role you will... ...prioritize bugs and work toward their resolution. Define and track quality assurance automation metrics such as automation defect...Tailored Brands Inc
Dublin, CA1 day ago- Mandatory Skills : Strong retail domain Experience, particularly in Promotions (Content Management Tool) experience should be in current projects, Selenium/java, BDD, Mobile Automation (Android & IOS), Jenkins, API Automation Strong in QA testing with 13+ Yrs...Flexible hours
Omni Inclusive
Dublin, CA3 days ago - ...QA Engineers Location: Fremont, CA Duration: 6Month Contract Job Responsibilities: Design and develop advanced test suites... ...platforms and programming languages to improve overall product quality and test coverage. Perform both functional testing and automation...Contract work
Perfict Global, Inc.
Fremont, CA3 days ago - ...QA Engineer Job Location: Fremont, CA (Remote till the Covid pandemic flattens) Job Type: Contract Responsibilities: Develop test strategy based on software requirements in an Agile test environment. Write test plans and test cases based on software functional...Contract workRemote work
InterSources
Fremont, CA2 days ago - ...Position: QA Engineer Location: Menlo Park, CA or Fremont, CA (Hybrid) Job type: Full time Job Summary:... ...and supporting evidence. Validate defect fixes and ensure quality closure across sprints and releases. Continuously adopt new...Full time
Futran Tech Solutions Pvt. Ltd.
Fremont, CA3 days ago - ...Software Testing Engineer Job Location: San Ramon, CA or Pleasanton, CA Job Type: Contract / Contract to hire Responsibilities: Develop a quality assurance strategy for the client. Develop automation scripts. Develop test plans, test data, and test cases...Contract work
InterSources
San Ramon, CA3 days ago - ...Mandatory Skills : Skills required: CodeCeptJS, JavaScript/Playwright, RestAPI, CI/CD, SQL, Agile Framework Migration Engineer to help us migrate our test automation framework from Protractor to Playwright/WDIO. The ideal candidate will have experience with given...
Omni Inclusive
San Ramon, CA23 hours ago - ...please visit us at . Follow @abbvie on LinkedIn, Facebook , Instagram , X and YouTube. Job Description The Senior Quality Engineer, Medical Device External Quality is part of AbbVie’s External and Product Quality Assurance group and reports to the Senior...Full timeContract workTemporary workLocal area
AbbVie Inc.
Pleasanton, CAa month ago - ...tolerances are measured in microns, our equipment is top-of-the-line, and our team is passionate about quality craftsmanship. About the Role We are seeking a Quality Engineer with hands-on manufacturing experience to support and improve the quality, reliability, and...Monday to FridayShift work
South Bay Solutions
Fremont, CA23 hours ago
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Quality Engineer. Be the first to apply!
Related searches
- senior quality systems engineer Pleasanton, CA
- supplier quality engineer Pleasanton, CA
- senior supplier quality engineer Pleasanton, CA
- senior quality engineer Pleasanton, CA
- senior manager quality engineering Pleasanton, CA
- quality engineer Pleasanton, CA
- quality systems engineer Pleasanton, CA
- customer quality engineer Pleasanton, CA
- senior data quality engineer Pleasanton, CA
- quality lead Pleasanton, CA