Sign up to access all features of our service.
  • Job search
  • Favorites
  • Create a CV
    New
  • Salaries
  • Subscriptions

Quality Systems Specialist

Delta Star

Quality Systems Specialist

The Quality Systems Specialist is responsible for supporting the development, implementation, maintenance, and continuous improvement of the company's Quality Management System (QMS) in alignment with business requirements and ISO 9001:2015 standards. This role leads quality system initiatives, internal and external audit activities, quality performance reporting, and systematic problem-solving efforts across multiple locations. Working collaboratively across functions and business units, the Quality Systems Specialist uses data, technical expertise, and influence to strengthen processes, drive corrective actions, and promote consistent quality practices throughout the organization.

Duties and Responsibilities

  • Lead the implementation, maintenance, and continuous improvement of the corporate Quality Management System, including QMS changes, documentation, corrective and preventive actions, and alignment with ISO 9001:2015 requirements
  • Develop and execute the corporate audit strategy, including planning, conducting, documenting, and following up on internal system and process audits and coordinating external registrar and customer audits
  • Partner with Site Quality Managers and cross-functional stakeholders to identify process gaps, facilitate problem-solving, implement systematic improvements, and promote consistent quality practices across locations
  • Develop, administer, analyze, and report corporate quality metrics and management review information to evaluate process performance, identify trends, and prioritize improvement opportunities
  • Build organizational auditing capability by training, developing, and supporting internal auditors and providing guidance on quality systems, auditing practices, and continuous improvement methodologies
  • Support corporate quality initiatives, including supplier qualification activities, employee QMS education, and other programs designed to strengthen quality performance and compliance
  • Facilitate cross-functional and multi-location teams in developing, reviewing, and improving QMS processes, procedures, and documentation
  • Lead internal system and process audits from preparation through execution, reporting, corrective action follow-up, and closure
  • Coordinate process audit activities with Site Quality Managers to support consistency between formal audit programs and ongoing process monitoring
  • Monitor improvement initiatives and establish appropriate measures to evaluate effectiveness and sustained performance
  • Prepare management review data, presentations, reports, and other quality-related information for leadership
  • Analyze quality and process performance data to identify trends, risks, improvement priorities, and educational needs
  • Coach employees and stakeholders in structured problem-solving and continuous improvement methodologies
  • Support supplier qualification activities and other quality assurance initiatives as needed
  • Develop and deliver introductory QMS education for new employees
  • Maintain current knowledge of applicable quality standards, auditing practices, and industry developments, including ISO 9001 requirements

Education and Experience

  • Bachelor's degree in Project Management, Business, Engineering, or another related discipline preferred
  • Minimum of three years of relevant experience in quality systems, manufacturing, quality engineering, or a related technical environment
  • Demonstrated experience working with ISO 9001:2015 Quality Management Systems
  • Experience conducting internal system and process audits, preferably serving as a lead auditor
  • Experience with supplier quality management, statistical analysis, structured problem-solving, control plans/FMEA, and continuous improvement methodologies
  • ISO 9001:2015 Lead Auditor certification preferred

Knowledge, Skills, and Abilities

  • Strong knowledge of Quality Management Systems, ISO 9001:2015 requirements, auditing principles, and continuous improvement practices
  • Demonstrated ability to lead initiatives and influence cross-functional teams without direct reporting authority
  • Strong analytical and problem-solving skills with the ability to interpret quality and process data and translate findings into actionable improvements
  • Effective interpersonal, facilitation, and collaboration skills with the ability to work across departments, locations, suppliers, customers, and organizational levels
  • Strong written and verbal communication skills, including the ability to develop concise reports, presentations, procedures, and training materials
  • Ability to teach, coach, and develop others in quality systems, auditing, problem-solving, and process improvement practices
  • Proficiency with Microsoft Office Suite and applicable quality management databases and software
  • Working knowledge of applicable inspection, testing, and measurement equipment used within a manufacturing environment
Vacancy posted 4 days ago
Similar jobs that could be interesting for youBased on the Quality Systems Specialist in San Carlos, CA vacancy
  • $87k - $100k

     ...Deerfield Healthcare, Cormorant Asset Management, and Invus Opportunities. SUMMARY OF ROLE: We are looking for a Quality Systems Specialist II with passion for creating devices that save lives. The Quality Systems Specialist II works closely with cross-functional... 
    Suggested
    Temporary work
    Local area
    Visa sponsorship
    Work visa
    Relocation package
    Flexible hours

    Element Science Inc

    Redwood City, CA
    2 days ago
  •  ...Quality Systems SpecialistThe Quality Systems Specialist is responsible for supporting the development, implementation, maintenance, and continuous improvement of the company's Quality Management System (QMS) in alignment with business requirements and ISO 9001:2015 standards... 
    Suggested
    Work at office

    Delta Star

    San Carlos, CA
    4 days ago
  • Element Science, Inc. is seeking a Quality Systems Specialist I to support CAPA processes and QMS activities in a fast-paced medical device environment. You will work cross-functionally with Manufacturing Engineering, Regulatory Affairs and R&D to drive quality improvements... 
    Suggested

    Element Science

    Redwood City, CA
    3 days ago
  •  ...Quality Systems Specialist The resource should have 2-3 years of prior experience in a regulated cGMP environment. Prior experience in the pharmaceutical/biotech sector is preferred. The resource should have a combination of experience in the Quality Assurance area... 
    Suggested

    Integrated Resources

    San Mateo, CA
    3 days ago
  • $45 - $65 per hour

    Job Title: Quality Systems Specialist Quality Systems Specialist manages and oversees change controls for products, processes, equipment, facilities, and computerized systems within a regulated manufacturing environment. This role ensures that changes align with quality... 
    Suggested
    Contract work
    Temporary work
    Work at office
    Local area

    Actalent

    San Mateo, CA
    4 days ago
  • $120k - $150k

     ...Program, ensuring document control processes, governance, and systems remain compliant, efficient and aligned with regulatory requirements...  ...improvement projects.Monitor, analyze, and communicate key quality metrics and KPIs related to document lifecycle management and process... 
    Full time
    Work at office
    Local area

    Revolution Medicines

    Redwood City, CA
    4 days ago
  • $117.9k - $152.57k

     ...atypical), CAPAs, change controls, protocols and reports.Maintains accurate, complete, and timely (ALCOA) quality records in accordance with GMP and quality systems.Supports QA team members in daily operations such as lot disposition and process improvement projects.... 
    Full time
    For contractors
    Work at office
    Local area

    GILEAD Sciences

    Foster, CA
    19 hours ago
  • $41.47 - $62.21 per hour

     ...to make rapid treatment decisions. Position Summary The Quality Assurance Associate is an enthusiastic, self-motivated person...  ...Responsibilities Supports / administers document control system, including revision and maintenance of lab documents to ensure... 
    Hourly pay
    Part time
    Work at office
    Local area
    Flexible hours

    Karius, Inc.

    Redwood City, CA
    1 day ago
  • $85k - $105k

     ...tier investors. Position Overview: We are seeking a Quality Assurance Specialist to support the day-to-day quality and compliance activities...  ...records within a QMS or electronic document management system (eQMS/EDMS). Strong organizational skills and attention... 
    Work at office

    MyOme

    Menlo Park, CA
    1 day ago
  • $130k - $145k

     ...Defense.We are seeking a hands-on Simulation Operations Specialist to join the Software Quality team. In this role, you will drive improvements across...  ...accurately reflect real-world conditions.Work closely with systems engineers on structured test design and execution,... 
    Temporary work
    Work at office
    Visa sponsorship

    Kodiak Robotics

    Mountain View, CA
    3 days ago
  • $114.7k - $212.9k

     ...streamlined processes to produce the highest quality medicines. This plant meets today’s...  ...impactful Principal Quality Compliance Specialist who possesses extensive experience in quality...  ...a robust, risk-based Quality Management System (QMS) across the site while championing... 
    Local area
    Relocation package

    F. Hoffmann-La Roche AG

    South San Francisco, CA
    2 days ago
  • $30 - $40 per hour

     ...Quality Document Specialist The Quality Document Specialist (QA Records Management Specialist) is responsible for managing physical and electronic...  ...of all records within the validated records management system. Advise stakeholders on current industry best practices... 
    Contract work
    Temporary work

    Actalent

    San Mateo, CA
    3 days ago
  • Corcept Therapeutics in Redwood City, CA, is seeking a Quality Specialist II, Quality Compliance, to perform day-to-day quality operations supporting...  ..., and external vendors to strengthen the quality system and readiness for inspections. This hybrid role requires on-site... 
    3 days per week

    Corcept Therapeutics

    Redwood City, CA
    5 days ago
  • $40 - $42 per hour

     ...Job Description .Kelly® Science & Clinical is seeking a Quality Assurance Specialist for a 6-month contract opportunity with one of our clients...  ...guidance preferred. ~ Familiarity with quality management systems and GDP requirements in a GMP environment. ~ Experience... 
    Hourly pay
    Contract work
    Temporary work
    Local area

    Kelly Services

    South San Francisco, CA
    10 days ago
  • $78.5k - $145.9k

     ...Lab Analyst, you will join our Global Analytical Development and Quality Control team, a leader in developing and executing testing...  ...accurate documentation of activities and transactions in applicable systems.You coordinate with customers to support operational activities... 
    Full time
    Local area
    Relocation package

    Genentech

    South San Francisco, CA
    14 hours ago
  •  ...A clinical-stage biotech company is seeking a Senior Specialist in Quality Assurance to oversee compliance and support quality investigation processes. The ideal candidate will have over 4 years of experience in a relevant role within the biotech sector and a Bachelor’... 

    Allakos Inc

    Redwood City, CA
    4 days ago
  •  ...Description QA Data Analyst & Telemetry Specialist IV Description: ~ We’re looking for...  ...Specialist to help drive our product quality efforts through insightful data analysis...  ...across environments, and analyze patterns in system behavior to support QA investigations... 

    Cypress HCM

    Mountain View, CA
    20 days ago
  • Karius is seeking a part-time Quality Assurance Associate to support the internal quality framework, document control, training tracking, and quality records. The role requires attention to detail and strong written communication, with experience in GLP and CAPAs preferred... 
    Hourly pay
    Part time

    Karius, Inc.

    Redwood City, CA
    4 days ago
  • $110.4k - $153k

     ...developing knowledge of relevant concepts and processes. Share Search Quality Analyst link Copy link Bachelor’s degree in Computer Science,...  ...for solution generation and action planning; Automated system improvement through data analysis; High-volume product data extraction... 
    Full time
    Work at office

    Google Inc.

    San Bruno, CA
    2 days ago
  • $4,827 - $5,425 per week

     ...Paid holidays, Co-paid medical, dental, and vision insurance, Cafeteria plan access and 401(k) retirement plan. Summary: The Interim Quality Nurse Consultant provides expertise in clinical quality, patient safety, regulatory compliance, risk management, and infection... 
    Full time
    Contract work
    Interim role
    Local area

    AZAD Technology Partners

    Redwood City, CA
    2 days ago
  • Karius is seeking a part-time Quality Assurance Associate in Redwood City, CA to support the internal quality framework, audits, CAPAs, deviations, and training. This role requires strong writing, organization, and collaboration across teams in a rapidly evolving biotech... 
    Hourly pay
    Part time

    Kariusdx

    Redwood City, CA
    4 days ago
  • Healthcare Executive Placements, Inc. (HCEPInc) is seeking an Interim Quality Nurse Consultant for a W2 contract position based in Redwood City, California. The role focuses on clinical quality, patient safety, regulatory compliance, and infection prevention, with data-... 
    Contract work
    Interim role

    AZAD Technology Partners

    Redwood City, CA
    2 days ago
  • Guardant Health in Redwood City, CA is seeking a Senior Clinical Laboratory Scientist to perform high complexity molecular testing, including next generation sequencing, and uphold QC/QA standards. This on-site role requires meticulous records and the ability to multi-task...

    Guardant Health

    Redwood City, CA
    2 days ago
  •  ...support a language and AI training project. You will evaluate Turkish audio content, assess linguistic quality, and provide precise feedback to help improve AI systems. No prior AI experience is required. Responsibilities include evaluating nativeness and pronunciation,... 
    Remote job

    YO AI Labs

    Palo Alto, CA
    1 day ago
  • $38 per hour

     ...Data Quality AnalystWelo Data is looking for experienced, detail-oriented professionals to join our team as Data Quality Analysts. This...  ..., but done right.You'll work closely with both people and AI systems — auditing outputs, supporting day-to-day execution, and helping... 
    Full time
    Contract work
    Remote work
    Visa sponsorship

    Welocalize

    Burlingame, CA
    3 days ago
  •  ...a Clinical Laboratory Scientist II in Redwood City, CA to perform high-complexity testing (Next generation DNA sequencing), ensure quality control, report patient results, and maintain compliant records. The role requires a California CLS license, a BA/BS in Biomedical... 

    Guardant Health, Inc.

    Redwood City, CA
    3 days ago
  •  ...built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical... 

    Careers Integrated Resources Inc

    San Mateo, CA
    3 days ago
  • OnePlus is seeking a Sr. Moderator for its Content Operations team. You will perform high-quality reviews of text, images, and videos, ensure alignment with guidelines, and report issues for timely action. You will contribute to policy improvements and generate daily audits... 
    For contractors

    OPPO US Research Center

    Palo Alto, CA
    4 days ago
  • $65k - $85k

     ...Quality Assurance AssociateAmpa is a pioneering neurotechnology startup developing brain stimulation technology to help eradicate depression. We will improve millions of lives by making this transformative treatment universally accessible. Joining us means you'll be part... 
    Full time

    AMPA

    Palo Alto, CA
    4 days ago
  •  ...A tech consulting firm is seeking a QA Data Analyst & Telemetry Specialist to enhance product quality through data analysis and reporting. In this hybrid role, you’ll work closely with engineering teams, create dashboards, and investigate product behavior through telemetry... 

    INFOMATICS

    Mountain View, CA
    2 days ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to Quality Systems Specialist. Be the first to apply!