Internal Audit Lead, Quality Assurance Specialist
3 days ago
We 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 Responsibilities- Conduct Audits: 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: 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: Perform root-cause analysis to identify compliance gaps and risks, providing results to leadership for further action.
- Drive Process Improvements: Drive process improvements to enhance systemic compliance and quality standards, utilizing ingenuity and creative problem-solving skills.
- Assist with Deviation and Audit Findings: Assist with deviation and audit findings, tracking, ensuring their effective execution, and coordinating timely closure of actions.
- Lead External Audits: Lead the front room for external audits (i.e., FDA or other notified bodies).
- Bachelor's Degree: Bachelor's degree in a relevant scientific or healthcare field.
- Experience: 4+ years of experience as an auditor.
- Regulatory Experience: Experience being in the front room for external audits (FDA or other notified bodies).
- GLP, GMP, and GCP Experience: Experience conducting audits of GLP, GMP, and GCP.
- Regulatory Knowledge: Working knowledge of FDA regulatory requirements and standards.
- Quality Assurance and Analytical Skills: Strong quality assurance and analytical skills.
- Communication and Collaboration: Excellent communication and collaboration abilities.
- Regulatory and Technical Writing: Experience with regulatory and technical writing.
- Engineering Background: Engineering background.
- International Regulatory Experience: Experience with international regulatory audits (TGA, EU, Health Canada, MDSAP).
- Supplier Audits: Experience with supplier audits.
- Internal Audit Program Leadership: Experience leading an internal audit program.
Based on California law, the following details are for California individuals only:
California base salary range: $103,000-$169,000 USD
For Full-Time Employees, your compensation package will include two major components: salary and equity. Guidance on salary for this role will be determined according to the level at which you enter the organization, with the ability to gain more over time as you contribute.
In addition, Full-Time Employees are eligible for the following benefits:
- Medical, Dental, and Vision Insurance: Excellent medical, dental, and vision insurance through a PPO plan.
- Paid Holidays: Paid holidays.
- Commuter Benefits: Commuter benefits.
- Meals Provided: Meals provided.
- Equity and 401(k) Plan: Equity + 401(k) plan *Temporary Employees & Interns excluded.
- Parental Leave: Parental leave *Temporary Employees & Interns excluded.
- Flexible Time Off: Flexible time off *Temporary Employees & Interns excluded.
-
Quality Assurance Specialist
12 hours ago
Fremont, California, United States Abbott Full timeAbout 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 Systems Specialist
2 weeks ago
Fremont, California, United States Actalent Full timeQuality Assurance Systems SpecialistPosition OverviewWe are seeking a dedicated Quality Assurance Systems Specialist to oversee and enhance the effectiveness of our Quality Management System (QMS). In this pivotal role, you will serve as a key intermediary between Global Quality Assurance and Site Quality Assurance, facilitating the resolution of Corrective...
-
Quality Assurance Specialist
2 weeks ago
Fremont, California, United States Hyve Solutions Full timeHyve 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 Automation Specialist
2 weeks ago
Fremont, California, United States Info Way Solutions Full timeGreetings Professionals,We are excited to present a career opportunity for a Quality Assurance Automation Specialist. Below is the detailed job overview:Position: Quality Assurance Automation SpecialistLocation: RemoteClient: Leading Technology FirmContract Type: Long Term EngagementEssential Skills:- Extensive experience in Quality Engineering Automation-...
-
Quality Assurance Specialist
1 week ago
Fremont, California, United States Abbott Full timeThe Opportunity This role involves performing internal quality assessments to ensure adherence to the standards set by regulatory authorities such as FDA, ISO, MDD, CDR, and others relevant to the Quality Management System. You will also engage in supporting the organization during external regulatory evaluations. Key Responsibilities This position...
-
Lead Auditor for Internal Compliance
2 weeks ago
Fremont, California, United States NeuroTech X Full timePosition Title: Lead Auditor for Internal ComplianceCompany: NeuroTech XLocation: RemoteCompany Overview:At NeuroTech X, we are pioneering advancements in brain-computer interface technology, developing innovative solutions aimed at empowering individuals with mobility challenges and enhancing human capabilities.Department Overview:Become a vital member of...
-
Quality Assurance Process Engineer
2 weeks ago
Fremont, California, United States Hyve Solutions Full timeAbout HYVE SolutionsHYVE Solutions is dedicated to empowering our clients, partners, and employees to achieve their objectives through collaborative goals, strategic initiatives, and innovative technology solutions.Compensation Package: $90K-120KCultural Values at HYVEAt HYVE Solutions, we strive to create value for all stakeholders at every interaction. Our...
-
Quality Assurance Process Engineer
2 weeks ago
Fremont, California, United States Hyve Solutions Full timeCompany OverviewAt HYVE Solutions, we are dedicated to empowering our clients, partners, and employees to achieve their objectives through collaborative strategies, resources, and innovative technology solutions.Compensation PackageSalary range: $90K-120KOrganizational CultureHYVE Solutions is committed to creating value for all stakeholders at every...
-
Quality Assurance Engineer
2 weeks ago
Fremont, California, United States Integration International Inc. Full timePosition: Quality Assurance EngineerCompany: Integration International Inc.Job Overview:We are seeking a dedicated Quality Assurance Engineer to join our team. This role involves overseeing and supporting the development of new products while ensuring compliance with our internal quality management system and relevant regulations.Key Responsibilities:Oversee...
-
Quality Assurance Specialist
3 days ago
Fremont, California, United States SilverTech Full timeAbout SilverTechSilverTech is a leading provider of quality management solutions in the field of psychosocial services. Our mission is to empower individuals and communities through innovative and effective quality management practices.Job SummaryWe are seeking a highly motivated and experienced Quality Officer to join our team. The successful candidate will...
-
Quality Assurance Specialist
1 week ago
Fremont, California, United States Millennium Metalcraft, Inc Full timeQuality Control Inspector at Millennium Metalcraft, Inc.Millennium Metalcraft, Inc. is a prominent manufacturing company in the sheet metal and machining industry. We are seeking a skilled Quality Control Inspector to join our team.Key Responsibilities:Inspecting parts for tolerances, craftsmanship, and defects.Analyzing parts against provided drawings and...
-
Quality Assurance Leader
2 weeks ago
Fremont, California, United States Gateway Recruiting, INC. Full timePosition 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...
-
Quality Assurance Lead
2 weeks ago
Fremont, California, United States Thought storm Full timePosition OverviewJob Title: Test ManagerCompany: Thought StormContract Duration: 12+ MonthsKey Responsibilities:As a Test Manager, you will oversee the testing processes for hardware components, ensuring that all products meet the highest standards of quality and performance. Your role will involve:Leading a team of test engineers and managing test...
-
Quality Assurance Leader
2 weeks ago
Fremont, California, United States Gateway Recruiting, INC. Full timePosition 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...
-
Senior Quality Assurance Engineer
2 weeks ago
Fremont, California, United States Akraya Full timeEssential Skills: Quality Control, Product Assessment, CAPA analysis, DFMEA & PFMEA, ISO/FDA/IVDR/QSRPosition: Senior Quality Assurance EngineerContract Type: W2 onlyCompensation: $56.50 Per HourKEY RESPONSIBILITIES:We are seeking a proficient Quality Assurance Engineer with a focus on medical devices to guarantee that our offerings adhere to all quality...
-
Senior Quality Assurance Engineer
2 weeks ago
Fremont, California, United States Maxonic Full timeMaxonic is committed to fostering enduring partnerships with our esteemed clients. To address their requirements, we are in search of a Senior Quality Assurance Engineer. Position Overview: Job Title: Senior Quality Assurance EngineerJob Type: Long-term Contract (Potential for Extension and Transition to Full-time)Location: RemoteCompensation: Competitive...
-
Microbiological Quality Assurance Specialist
2 weeks ago
Fremont, California, United States Compunnel Inc. Full timePosition OverviewAs a Microbiological Quality Assurance Specialist, you will play a crucial role in ensuring the integrity and quality of our products through rigorous testing and adherence to industry standards.Key ResponsibilitiesTesting Coordination: Manage and execute both routine and specialized testing in Quality Control Microbiology for various drug...
-
Quality Assurance Engineer in Manufacturing
2 weeks ago
Fremont, California, United States TekWissen LLC Full timeJob DescriptionOverviewTekWissen Group is a prominent workforce management provider operating across the USA and various international markets. The following opportunity is with one of our esteemed clients, who specialize in the development of biotechnology products. This organization is committed to delivering essential laboratory equipment, chemicals,...
-
Senior Quality Assurance Engineer
2 weeks ago
Fremont, California, United States Tekwissen Full timeOverview TekWissen Group is a prominent workforce management provider operating across the USA and globally. The opportunity presented below is with one of our esteemed clients, a leader in biotechnology product development services. This organization is committed to providing essential laboratory equipment, chemicals, supplies, and services that are vital...
-
Quality Assurance Leader
2 weeks ago
Fremont, California, United States Gateway Recruiting, INC. Full timePosition OverviewThe Quality Improvement Manager plays a pivotal role in overseeing and enhancing the established 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 routine...