Quality Assurance Specialist jobs in California
Quality Assurance Specialist implements company and regulatory quality standards for product manufacturing. Knowledgeable of industry and governmental quality regulations. Being a Quality Assurance Specialist audits and reviews quality data according to existing procedures. Documents results in required format. Additionally, Quality Assurance Specialist requires a bachelor's degree or equivalent. Typically reports to a manager or head of a unit/department. The Quality Assurance Specialist work is closely managed. Works on projects/matters of limited complexity in a support role. To be a Quality Assurance Specialist typically requires 0-2 years of related experience. (Copyright 2024 Salary.com)
Recently Added Quality Assurance Specialist jobs
Quality Assurance 3 / Sr. Quality Assurance Specialist
- Truvian Sciences
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San Diego, CA
FULL_TIME
-
ABOUT
Want to work for a fast-paced and disruptive company that is working to revolutionize blood testing? Truvian is a healthcare company at the intersection of diagnostics and consumer tech. We are developing an automated benchtop diagnostic system to provide lab-accurate results in 20 minutes for a comprehensive suite of health tests. Our proprietary approach, for which we are seeking FDA clearance, is intended to fulfill the promise of delivering accessible and affordable blood testing from a tiny blood sample in minutes in a retail setting or private clinic.
To us, our work at Truvian is more than a job—it’s a mission. We are a culture dedicated to discovery and empowerment. We are trailblazers on the path to putting health information where it belongs—in the hands of the individual. We are partners in the belief that talented people working as a team can make every day an adventure. Join us as we realize our vision to make routine health testing convenient, affordable, and actionable for today’s connected consumers!
JOB SUMMARY
The role will be responsible for Quality Assurance and interacting with cross-functional departments to provide quality guidance.
WHAT YOU WILL DO:- Represent Quality Assurance and interact with cross-functional departments to provide quality guidance by reviewing documents, suggesting improvements, and participating in design reviews or technical workstreams.
- Ensure compliance with all relevant ISO and FDA GMP regulatory requirements (e.g., ISO 13485, 21 CFR 820).
- Responsible for batch record and IQA releases.
- Supervise and direct the document control team in executing document and change control processes to ensure the standardization, accuracy, and completeness of documents prior to release.
- Mentor, train, set priorities, and perform an evaluation of document control team.
- Stakeholder in developing, implementing, and continually improving quality systems within the QA department.
- Take the initiative on any QA-related issues concerning compliance and propose resolutions.
- Leads the document control management system within the company’s quality system and implements necessary improvements within electronic systems capabilities, e.g., EQMS and ERP system. Acts as primary administrator.
- Participates in compliance audits with FDA and certifying bodies.
- Responsible for collating information to support the quarterly Quality Management Review. Establish regularly scheduled updates with cross-functional departments to collect quality metric data to support the QMR.
- Owns selected QA processes (e.g. CAPA, NCR, Deviations, Audit), as assigned.
- Analyze, prepare, and report quality metrics for improvement.
- Recognizes internal and external continuous improvement opportunities and drives them to the desired state (See it, Own it, Do it).
- Active participant and contributor to supporting creation of appropriate change control, validation and qualification documentation associated with complex issues.
- Oversee the Truvian Quality System training program to ensure compliance (e.g., new hire).
- Take responsibility for the ongoing maintenance, audit, and continuous improvement of the Quality Management System, to ensure compliance to the ISO, IVDD and FDA requirements.
- Perform Internal/External audits as well as prepare written correspondence regarding QA Audits and compliance audit findings.
- Bachelor of Science in engineering, physical or life sciences
- 5 or more years of relevant experience in quality assurance in the medical device industry.
- Advanced familiarity with IVD and biotech manufacturing processes and procedures, including acceptance activities, production and process controls, identification and traceability, quality auditing, etc.
- Experience in planning, coordinating, and documenting controlled studies, including protocol development.
- Demonstrated ability to lead fast-track investigations through analysis to outcomes for decision.
- Certifications, Licenses, Registrations: Audit Certification preferred.
• No
SALARY RANGE
$106,000 - $125,000
This range considers the factors considered in making compensation decisions, including but not limited to experience, skills, knowledge, abilities, education, licensure and certifications, and other business and organizational needs. Salary offers are determined based on the final candidate's qualifications and experience. Placement within the compensation range is determined by internal equity and relevant qualifications.
PHYSICAL DEMANDS AND ABILITIES- Regularly required to use hands to finger, handle or feel, reach with hands and arms, and talk or hear
- Ability to lift and move over 25 lbs repeatedly and safely, occasionally 75 lbs with assistance
- Frequently required to stand, walk, stoop, kneel, crouch or crawl
- Occasionally required to sit and climb or balance
- Specific vision abilities required for this job include close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust and focus
- Good motor skills and the ability to do fine assembly
- 4 Days Ago
Quality Assurance Specialist
- Actalent
-
IRVINE, CA
OTHER
- Description: • Performs and/or assists with QA review of production records and Lab reports. • Investigates non-conformance and deviation reports. • Coordinates the stability studies including reviewi...
- 2 Days Ago
Quality Assurance Specialist II
- IDR, Inc.
-
Newark, CA
FULL_TIME
- IDR is actively seeking a talented Quality Assurance Specialist II to join one of our healthcare clients for a 6 month contract with the potential to convert. This will be an onsite position in Newark...
- 3 Days Ago
Quality Assurance Specialist
- AppleOne Employment Services
-
Redlands, CA
FULL_TIME
- QualificationsEducation: High school diploma or equivalency (required).Experience: 2 prior years of relevant experience (preferred)Excellent organizational skills and attention to detailStrong Interpe...
- 4 Days Ago
Quality Assurance Data Specialist
- Honeyville, Inc.
-
Rancho Cucamonga, CA
OTHER
- The QA Specialist reviews documentation, assists in the management of QMS programs, documents and processes.Core ResponsibilitiesReview raw material COAs and release raw materials for use in productio...
- 8 Days Ago
Quality Assurance Specialist
- Bell Bros
-
Rancho Cordova, CA
FULL_TIME
- The Role: As a Quality Assurance Specialist at Bell Brothers, you will play a crucial role in identifying and qualifying potential customers, driving lead generation, and contributing to the sales pip...
- Just Posted
Quality Assurance Specialist jobs at Popular Companies
Quality Assurance Specialist
- American Honda Motor Co.
-
Anna, OH
- What Makes a Honda, is Who makes a Honda Honda has a clear vision for the future, and it’s a joyful one. We are looking ...
- 6/11/2024 12:00:00 AM
Quality Assurance Specialist
- ClinLab Staffing
-
Lowell, MA
- QA Specialist Location: Lowell, MA Summary of Primary Responsibilities: The Quality Assurance (QA) Compliance Specialist...
- 6/10/2024 12:00:00 AM
Quality Assurance Specialist
- SPECTRAFORCE
-
Newark, CA
- Job Title: Quality Assurance Specialist II Duration: 6+ Months Location: Newark, CA (94560) Job Summary: The Quality Ass...
- 6/10/2024 12:00:00 AM
Quality Assurance Specialist
- Eaton Aerospace
-
Grand Rapids, MI
- Eaton's AER HQ Headquarters division is currently seeking a Quality Assurance Specialist. This position will support our...
- 6/9/2024 12:00:00 AM
Quality Assurance Specialist
- SKF
-
Muskegon, MI
- Quality Assurance Specialist Location: Muskegon, MI Shift: 2nd (3:15 pm to 11:30 pm) About SKF: SKF has been making the ...
- 6/9/2024 12:00:00 AM
Quality Assurance Specialist
- PrognomiQ Inc
-
- PrognomiQ is developing transformative test products that enable early disease detection and treatment. At PrognomiQ we ...
- 6/8/2024 12:00:00 AM
Quality Assurance Specialist
- LHH
-
- **Responsibilities:** - Ensure compliance with all company policies and procedures. - Monitor project progress to ensure...
- 6/8/2024 12:00:00 AM
Quality Assurance Specialist
- PARLUX LTD.
-
Bellport, NY
- Company Description PARLUX LTD. is a leading global beauty manufacturer based in Bellport, NY. We design, market, and di...
- 6/8/2024 12:00:00 AM
About California
California is a state in the Pacific Region of the United States. With 39.6 million residents, California is the most populous U.S. state and the third-largest by area. The state capital is Sacramento. The Greater Los Angeles Area and the San Francisco Bay Area are the nation's second and fifth most populous urban regions, with 18.7 million and 9.7 million residents respectively. Los Angeles is California's most populous city, and the country's second most populous, after New York City. California also has the nation's most populous county, Los Angeles County, and its largest county by area, S...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Quality Assurance Specialist jobs
$68,175 to $86,311
Most Popular Cities in California for Quality Assurance Specialist Jobs
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