Internal Audit Lead, Quality Assurance

3 weeks ago

Fremont, California, United States Neuralink Full time
Job Summary

We are seeking a highly skilled Internal Audit Lead, Quality to join our Quality Team at Neuralink. As a key member of our team, you will be responsible for ensuring compliance with relevant regulatory standards and driving process improvements to enhance systemic compliance and quality standards.

Key Responsibilities
  • Conduct audits of GLP, GMP, GCP, and engineering activities within Neuralink, ensuring adherence to U.S. FDA regulatory requirements, applicable standards, and Neuralink policies.
  • Identify and define audit scope and criteria, review evidence, analyze findings to assess compliance levels, and provide recommendations for improvement and corrective actions as needed.
  • Perform root-cause analysis to identify compliance gaps and risks, providing results to leadership for further action.
  • Drive process improvements to enhance systemic compliance and quality standards, utilizing ingenuity and creative problem-solving skills.
  • Assist with deviation and audit findings, tracking, ensuring their effective execution, and coordinating timely closure of actions.
  • Lead the front room for external audits (i.e., FDA or other notified bodies).
Requirements
  • Bachelor's degree in a relevant scientific or healthcare field.
  • 4+ years of experience as an auditor.
  • Experience being in the front room for external audits (FDA or other notified bodies).
  • Experience conducting audits of GLP, GMP, and GCP.
  • Working knowledge of FDA regulatory requirements and standards.
  • Strong quality assurance and analytical skills.
  • Excellent communication and collaboration abilities.
  • Experience with regulatory and technical writing.
Preferred Qualifications
  • Engineering background.
  • Experience with international regulatory audits (TGA, EU, Health Canada, MDSAP).
  • Experience with supplier audits.
  • Experience leading an internal audit program.
What We Offer
  • An opportunity to change the world and work with some of the smartest and most talented experts from different fields.
  • Growth potential; we rapidly advance team members who have an outsized impact.
  • Excellent medical, dental, and vision insurance through a PPO plan.
  • Paid holidays.
  • Commuter benefits.
  • Meals provided.
  • Equity + 401(k) plan *Temporary Employees & Interns excluded.
  • Parental leave *Temporary Employees & Interns excluded.
  • Flexible time off *Temporary Employees & Interns excluded.

Neuralink provides equal opportunity in all of our employment practices to all qualified employees and applicants without regard to race, color, religion, gender, national origin, age, disability, marital status, military status, genetic information or any other category protected by federal, state and local laws.

  • Internal Audit Lead, Quality Assurance Specialist

    3 weeks ago

    Fremont, California, United States Neuralink Full time

    Job SummaryWe are seeking a highly skilled Internal Audit Lead, Quality Assurance Specialist to join our Quality Team at Neuralink. As a key member of our team, you will be responsible for ensuring compliance with relevant regulatory standards and driving process improvements to enhance systemic compliance and quality standards.Key ResponsibilitiesConduct...

  • Quality Assurance Intern

    1 week ago

    Fremont, California, United States Thermo Fisher Scientific Full time

    Quality Assurance Internship OpportunityThermo Fisher Scientific is seeking highly motivated and detail-oriented individuals to join our team as Quality Assurance Interns. As a Quality Assurance Intern, you will have the opportunity to work on various projects that impact the quality of our products and services.Responsibilities:Partner with leadership to...

  • Quality Assurance Specialist

    3 weeks ago

    Fremont, California, United States Abbott Full time

    About the RoleThis is an exciting opportunity to join Abbott's Diabetes Care division as a Quality Assurance Specialist. As a key member of our team, you will play a critical role in ensuring the quality and compliance of our products and processes.Key ResponsibilitiesLead and support internal and external audits to maintain compliance with regulatory...

  • Quality Assurance Lead 2nd Shift

    1 week ago

    Fremont, California, United States Kraft Heinz Company Full time

    Job Title: Quality Assurance Lead 2nd ShiftWe are seeking a highly skilled Quality Assurance Lead to join our team at the Kraft Heinz Company's sauces processing facility in Fremont, OH.Job Summary:The successful candidate will be responsible for leading and motivating a team of quality assurance professionals, ensuring the highest standards of quality and...

  • Quality Assurance Specialist

    7 hours ago

    Fremont, California, United States Tek Support Full time

    Quality Assurance SpecialistWe are seeking an experienced Quality Assurance Specialist to join our team at Tek Support in Alameda, CA. The ideal candidate will play a key role in ensuring product quality and compliance with regulatory requirements in the medical device industry.Responsibilities:Regulatory Compliance: Ensure compliance with FDA, ISO 13485,...

  • Senior Quality Assurance Lead

    3 weeks ago

    Fremont, California, United States Info Way Solutions Full time

    About the Role:We are seeking a highly skilled Senior Quality Assurance Lead to join our team at Info Way Solutions. As a key member of our quality assurance team, you will be responsible for developing and implementing software test strategies, plans, and processes to ensure the delivery of high-quality products.Key Responsibilities:Develop and implement...

  • Quality Assurance Manager

    6 days ago

    Fremont, California, United States PSG Global Solutions Careers Full time

    Job Title: QA Interim ManagerAt PSG Global Solutions Careers, we're seeking a highly skilled QA Interim Manager to join our team. As a key member of our Quality Assurance group, you will play a critical role in ensuring the highest standards of quality in our pharmaceutical and medical products.Job SummaryWe're looking for a seasoned QA professional with...

  • Quality Assurance Specialist

    2 weeks ago

    Fremont, California, United States Supernal Full time

    About SupernalSupernal is an Advanced Air Mobility company that's pushing the boundaries of human possibility. We're developing an electric vertical take-off and landing (eVTOL) vehicle and the ground-to-air ecosystem to support the emerging industry.Job SummaryWe're seeking a Senior Quality Engineer to join our dynamic team. As a key member of our Quality...

  • Senior Quality Assurance Engineer

    3 weeks ago

    Fremont, California, United States Supernal Full time

    About SupernalSupernal is a pioneering Advanced Air Mobility company that's revolutionizing the future of transportation. Our mission is to create a sustainable, integrated, and human-centered ecosystem that meets the high standards of safety and reliability in the air transportation industry.Job SummaryWe're seeking a highly skilled Senior Quality Assurance...

  • Internal Audit Specialist

    2 weeks ago

    Fremont, California, United States Aurora Technologies Full time

    About Aurora TechnologiesWe are a leading developer of business parks in Germany, transforming former industrial sites into modern workspaces. Our 70+ parks offer flexible workspaces for small and medium-sized businesses.What Sets Us ApartOur service and commercial spaces are tailored to meet the needs of our tenants. We offer a unique combination of...

  • Quality Assurance Specialist

    2 weeks ago

    Fremont, California, United States Supernal Full time

    About the RoleWe are seeking a highly skilled Senior Quality Engineer to join our team at Supernal. As a key member of our Quality Assurance organization, you will play a critical role in ensuring the quality and reliability of our products and processes.Key ResponsibilitiesDevelop and implement quality plans, inspection and test methods, and procedures to...

  • Quality Assurance Specialist

    4 weeks ago

    Fremont, California, United States Hyve Solutions Full time

    Hyve Solutions is a leading provider of innovative technology solutions dedicated to supporting customers, business partners, and employees in achieving shared goals.Job Summary:We are seeking a highly skilled Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for conducting inspections, performing...

  • Quality Assurance Manager

    2 weeks ago

    Fremont, California, United States KH Manufacturing - North America Full time

    Job Title: Quality SupervisorJob Summary:The Quality Supervisor will lead the quality food safety initiatives on off shift while supporting Sanitation supervision on 3rd shift. This role is instrumental to the daily success of the facility, ensuring compliance with Kraft Heinz policies, KHMS, HACCP, FDA regulations, FSSC, religious laws, and state laws.Key...

  • Quality Assurance Manager

    5 days ago

    Fremont, California, United States Hyve Solutions Full time

    Job SummaryAs a Quality Inspection Manager at Hyve Solutions, you will play a critical role in ensuring the development and maintenance of quality evaluation, control systems, and protocols for processing materials into partially finished or finished products. Your expertise will be instrumental in managing audits of quality systems, identifying...

  • Quality Assurance Specialist

    2 weeks ago

    Fremont, California, United States QAPEL MEDICAL INC Full time

    Job Title: Quality Systems SpecialistWe are seeking a highly motivated and detail-oriented Quality Systems Specialist to join our team at Q'Apel Medical Inc. This role will play a critical part in ensuring the quality and compliance of our medical devices.Key Responsibilities:Process Engineering Change Notices (ECOs) and other Quality Management System...

  • Quality Assurance Leader

    1 month ago

    Fremont, California, United States Gateway Recruiting, INC. Full time

    Position OverviewThe Quality Improvement Manager is accountable for overseeing and enhancing the existing quality management systems and fostering a robust quality culture within the organization.Key Responsibilities:Provide guidance on strategies to reduce quality-related issues.Create and execute necessary quality documentation.Conduct regular audits of...

  • Senior Quality Assurance Specialist

    2 weeks ago

    Fremont, California, United States Info Way Solutions Full time

    Sr. Quality Assurance Analyst Job DescriptionInfo Way Solutions is seeking a highly skilled Sr. Quality Assurance Analyst to join our team. As a key member of our quality assurance team, you will be responsible for developing and implementing software test strategies, plans, and processes to ensure the delivery of production-ready code.Key...

  • Quality Assurance Leader

    1 month ago

    Fremont, California, United States Gateway Recruiting, INC. Full time

    Position OverviewThe Quality Systems Manager is a key role within Gateway Recruiting, INC., reporting directly to the Plant Manager. This position is essential for overseeing and enhancing the existing quality management systems and fostering a robust quality culture within the organization.Key Responsibilities:Provide guidance on strategies to reduce...

  • Quality Assurance Specialist

    5 days ago

    Fremont, California, United States Asahi Kasei Full time

    Job DescriptionBionova, a subsidiary of Asahi Kasei Medical, is seeking a Quality Assurance Compliance Specialist to join our team. As a rapidly growing biologics CDMO, we are committed to developing and manufacturing recombinant protein products using mammalian cell culture processes.Key ResponsibilitiesEnsure products and processes meet established quality...

  • Quality Assurance Specialist

    2 weeks ago

    Fremont, California, United States Centuri Group, Inc. Full time

    About the RoleWe are seeking a Quality Auditor to promote and audit all aspects of our Quality program, ensuring our crew's working environment is safe and compliant with industry standards.Key ResponsibilitiesEnsure field operations teams adhere to quality policies and proceduresConduct internal quality control audits, provide incident reports, and...