Quality Assurance Analyst, Sr. - Healthcare jobs in San Jose, CA

Quality Assurance Analyst, Sr. - Healthcare analyzes quality assurance and compliance data and prepares reports. Designs solutions to quality management issues. Being a Quality Assurance Analyst, Sr. - Healthcare may assist in the implementation of quality improvement processes. May assist less experienced analysts. Additionally, Quality Assurance Analyst, Sr. - Healthcare requires a bachelor's degree. Typically reports to a supervisor or manager. The Quality Assurance Analyst, Sr. - Healthcare occasionally directed in several aspects of the work. Gaining exposure to some of the complex tasks within the job function. To be a Quality Assurance Analyst, Sr. - Healthcare typically requires 2 -4 years of related experience. (Copyright 2024 Salary.com)

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Sr Quality Assurance Engineer
  • Telos Health, Inc.
  • Campbell, CA FULL_TIME
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    Job Title: Senior Quality Assurance Engineer
    Location: This position is based in our Campbell, California offices.
    Why Telos Health?
    At Telos Health we are developing novel robotic-assisted technologies and interventional capabilities that will forever change the disparate outcomes of ischemic stroke – a disease that impacts close to a million people a year in the U.S., and 10 million worldwide.  Not only is Telos changing the way stroke is treated, but also bringing this treatment to the greater population who is currently without. We are actively building a team who is focused on developing novel solutions for this complex disease – a disease in which one in four adults will face in their lifetime.
    What You’ll Do:
    This position provides Quality Engineering support in the development, manufacture and distribution of Imperative Care (Telos Health)’s medical device products consistent with the Company’s Quality Policy and Quality Objectives and to ensure our products and services meet the highest standards.
    • Implement and maintain Quality Management System processes, procedures, and techniques.
    • Provide quality support for medical device R&D and manufacturing activities throughout all phases of the product development process (e.g. requirement development, specification development, verification and validation testing, design transfer, risk assessment, usability, design change control).
    • Participate and support the development of product design history file and ensure compliance to internal processes and external standards and regulations.
    • Perform Document Control activities.
    • Collaborates with team members to define requirements, specifications, testing, and component/product acceptance activities.
    • Participate in risk management process ensuring that all the risks were properly identified/assessed and update risk management files accordingly.
    • Responsible for managing the Incoming Quality Control and other QC activities.
    • Direct interaction with suppliers to qualify and maintain approved supplier status, as well as oversee supplier process validation activities.  May be required to evaluate supplier notification of change and recommend necessary actions to maintain compliance.   
    • Review DCO’s involving product or process changes to ensure consistency with company procedures and quality system compliance.
    • Support projects in an aggressive manner consistent with corporate objectives. 




    What You’ll Bring:
    • Bachelor’s degree in related field (science, industrial operations, mechanical, biomedical, or electrical engineering) and a minimum of 5 years’ work experience (or Master’s and 3 years) in the medical device, or related regulated industry experience.
    • Experience working with electro-mechanical medical device, robotics, or medical software is highly desired.
    • Experience in Quality, Manufacturing, or Research and Development experience in a medical device or other regulated industry.
    • Strong knowledge of FDA requirements for design control of medical devices and 21 CFR 820, ISO 13485, 14971; IEC 60601-1, Cybersecurity, and related regulations
    • Experience addressing supplier or process issues (CAPAs, NCMR/NCRs, SCARs, etc.)
    • Excellent communications skills (both written and verbal)
    • Must be able to write clear, concise, and well thought out technical documentation with a focus on element of traceability, external standard or regulations rationale, risk management.
    • Must be able to perform multiple tasks concurrently with accuracy.

    Employee Benefits include a stake in our collective success with stock options, competitive salaries, a 401k plan, health benefits, generous PTO, and a parental leave program.

    Join Us! Apply today.

    Salary Range: $118,000-127,000 annually
    Please note that the salary information is a general guideline only. Imperative Care considers factors such as scope and responsibilities of the position, candidate's work experience, education/training, key skills, and internal equity, as well as location, market and business considerations when extending an offer.  As part of our total rewards package, Imperative Care offers comprehensive benefits including a 401k plan, health benefits, generous PTO, a parental leave program and emotional health resources.
  • 1 Month Ago

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Sr Manager, CMC Quality Assurance
  • Kaztronix
  • Menlo, CA FULL_TIME
  • Company is seeking a Senior Manager, CMC Quality Assurance, to help lead quality for Company's Client oncology therapies. The Senior Manager of CMC Quality Assurance will be responsible for building t...
  • 21 Days Ago

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Sr. Engineering Manager - Quality Assurance
  • TigerGraph
  • Redwood, CA FULL_TIME
  • Sr. Engineering Manager - Quality Assurance TigerGraph is a platform for advanced analytics and machine learning on connected data. TigerGraph's core technology is the only scalable graph database for...
  • 10 Days Ago

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Sr. Quality Assurance Specialist (GLP)
  • AMADOR BIOSCIENCE INC
  • Pleasanton, CA FULL_TIME
  • Amador Bioscience (AmadorBio) is a Translational & Clinical Pharmacology CRO providing global-standard services in quantitative clinical pharmacology, GLP/GCLP bioanalysis, clinical research, and regu...
  • 1 Month Ago

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Senior Quality Assurance Analyst-ProdDev
  • Oracle
  • Santa Clara, CA FULL_TIME
  • We are looking for QA engineers who thrive in a dynamic, cross functional, collaborative culture and you will be working with the latest Cloud technologies to deliver a SaaS based web enterprise appli...
  • 17 Days Ago

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IT Quality Assurance Analyst 2
  • Stanford University
  • Redwood, CA FULL_TIME
  • Job Purpose: Under general supervision, verify correct functionality of software by testing and analyzing systems (applications and/or services). May serve as quality assurance lead. Core Duties: Part...
  • 22 Days Ago

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0 Quality Assurance Analyst, Sr. - Healthcare jobs found in San Jose, CA area

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Senior Quality Assurance Analyst-ProdDev Bay Area
  • Oracle
  • Santa Clara, CA
  • Job Description We are looking for QA engineers who thrive in a dynamic, cross functional, collaborative culture and you...
  • 4/25/2024 12:00:00 AM

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Salesforce LWC Developer
  • Jade Global
  • San Jose, CA
  • Job Overview: The Salesforce LWC Developer plays a key role in developing, customizing, and maintaining Salesforce Light...
  • 4/25/2024 12:00:00 AM

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Inventory Control & Quality Assurance Analyst
  • Weee!, Inc.
  • Milpitas, CA
  • **Inventory Control & Quality Assurance Analyst** at Weee! Inc Milpitas, California, United States ****About Weee!**** a...
  • 4/24/2024 12:00:00 AM

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IT Software Developer
  • Stanford University
  • Redwood City, CA
  • Stanfords University Information Technology (UIT) organization services diverse clientele from various university busine...
  • 4/24/2024 12:00:00 AM

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JUNIOR MANUAL QA ANALYST - CONTRACT - REMOTE - USC OR GC NO C2C NO C2H
  • System Soft Technologies
  • San Jose, CA
  • MANUAL QA TESTER - CONTRACT TO HIRE - REMOTE EASTERN TIME ZONE ONLY - USC , GC, NO C2C We seek a MANUAL QA TESTER for a ...
  • 4/23/2024 12:00:00 AM

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IT Software Developer (Oracle APEX)
  • Stanford University
  • Redwood City, CA
  • Stanfords University Information Technology (UIT) organization services diverse clientele from various university busine...
  • 4/23/2024 12:00:00 AM

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JUNIOR MANUAL QA ANALYST - CONTRACT - REMOTE - USC OR GC NO C2C NO C2H
  • System Soft Technologies
  • San Jose, CA
  • MANUAL QA TESTER - CONTRACT TO HIRE - REMOTE EASTERN TIME ZONE ONLY - USC , GC, NO C2C We seek a MANUAL QA TESTER for a ...
  • 4/21/2024 12:00:00 AM

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Board Certified Behavior Analyst - BCBA
  • Spectrum Center Schools and Programs
  • San Jose, CA
  • Spectrum Center Schools and Programs, a growing, dynamic organization with a social mission to offer hope, is seeking a ...
  • 3/6/2024 12:00:00 AM

San Jose is located at 37°20′07″N 121°53′31″W / 37.335278°N 121.891944°W / 37.335278; -121.891944. According to the United States Census Bureau, the city has a total area of 180.0 sq mi (466 km2), of which 3.4 sq mi (8.8 km2) (1.91%) is water, making it the fourth-largest California city by land area (after Los Angeles, San Diego and California City). San Jose lies between the San Andreas Fault, the source of the 1989 Loma Prieta earthquake, and the Calaveras Fault. San Jose is shaken by moderate earthquakes on average one or two times a year. These quakes originate just east of the city on...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Quality Assurance Analyst, Sr. - Healthcare jobs
$98,777 to $127,553
San Jose, California area prices
were up 2.9% from a year ago