61 Quality Assurance 3 / Sr. Quality Assurance Specialist Jobs in San Diego, CA
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The Henry M. Jackson Foundation for the Advancement of Military Medicine
San Diego, CA | Full Time
$94k-113k (estimate)
3 Months Ago
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Quality Assurance 3 / Sr. Quality Assurance Specialist
$101k-122k (estimate)
Full Time | Scientific Services
2 Weeks Ago
Truvian Sciences is Hiring a Quality Assurance 3 / Sr. Quality Assurance Specialist Near San Diego, CA
ABOUTWant 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.
- 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
Job Summary
JOB TYPE
Full Time
INDUSTRY
Scientific Services
SALARY
$101k-122k (estimate)
POST DATE
06/07/2024
EXPIRATION DATE
09/03/2024
WEBSITE
truvianhealth.com
HEADQUARTERS
SAN DIEGO, CA
SIZE
50 - 100
FOUNDED
2015
TYPE
Private
CEO
JEFF HAWKINS
REVENUE
$5M - $10M
INDUSTRY
Scientific Services
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About Truvian Sciences
Truvian Sciences is a California-based developer of desktop analyzers that provides blood testing and diagnostics solutions for health clinics.
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