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Remote Medical Device Auditor Jobs in California

Vaxcyte

Manager, Supplier & Internal Auditor

San Carlos, CA · On-site +1

$151K - $176K/yr

... medical device industries. Essential Functions: * Supplier Audits * Plan, schedule, and conduct ... and remote) in support of supplier qualification and ongoing oversight programs. * Evaluate ...

YO AI Labs

Medical Auditor - Remote

San Jose, CA · Remote

$50 - $70/hr

Medical Auditor Job Type: Contractor Location: Remote Job Overview We are seeking experienced Medical Auditors to contribute their specialized expertise to an innovative healthcare AI project. In ...

YO AI Labs

Medical Auditor - Remote

San Francisco, CA · Remote

$50 - $70/hr

Medical Auditor Job Type: Contractor Location: Remote Job Overview We are seeking experienced Medical Auditors to contribute their specialized expertise to an innovative healthcare AI project. In ...

YO AI Labs

Medical Auditor - Remote

Los Angeles, CA · Remote

$50 - $70/hr

Medical Auditor Job Type: Contractor Location: Remote Job Overview We are seeking experienced Medical Auditors to contribute their specialized expertise to an innovative healthcare AI project. In ...

YO AI Labs

Medical Auditor - Remote

Palo Alto, CA · Remote

$50 - $70/hr

Medical Auditor Job Type: Contractor Location: Remote Job Overview We are seeking experienced Medical Auditors to contribute their specialized expertise to an innovative healthcare AI project. In ...

YO AI Labs

Medical Auditor - Remote

Palo Alto, CA · Remote

$55 - $70/hr

Medical Auditor Job Type: Contractor Location: Remote Job Overview We are seeking experienced Medical Auditors with strong expertise in outpatient professional fee coding and coding audits ...

YO AI Labs

Medical Auditor - Remote

Los Angeles, CA · Remote

$55 - $70/hr

Medical Auditor Job Type: Contractor Location: Remote Job Overview We are seeking experienced Medical Auditors with strong expertise in outpatient professional fee coding and coding audits ...

YO AI Labs

Medical Auditor - Remote

San Francisco, CA · Remote

$55 - $70/hr

Medical Auditor Job Type: Contractor Location: Remote Job Overview We are seeking experienced Medical Auditors with strong expertise in outpatient professional fee coding and coding audits ...

YO AI Labs

Medical Auditor - Remote

San Jose, CA · Remote

$55 - $70/hr

Medical Auditor Job Type: Contractor Location: Remote Job Overview We are seeking experienced Medical Auditors with strong expertise in outpatient professional fee coding and coding audits ...

Prismatik

Project Manager - Medical Device

Irvine, CA · On-site +1

$81K - $115K/yr

Minimum three (3) years of experience in project management; medical device industry experience, a ... Remote or hybrid arrangements are not available. Employment Type: full-time

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Remote Medical Device Auditor information

What is a remote medical device auditor?

Remote Medical Device Auditors are professionals who evaluate medical device manufacturers' compliance with regulatory standards and quality systems, such as ISO 13485, without being physically present at the site. They conduct audits using digital tools, video conferencing, and document reviews to ensure products meet safety and quality requirements. This role requires strong knowledge of medical device regulations and excellent communication skills to work effectively with clients and regulatory bodies from a distance.

What skills and qualifications are needed to thrive as a remote medical device auditor?

To thrive as a Remote Medical Device Auditor, you need a solid understanding of medical device regulations (such as ISO 13485, FDA 21 CFR Part 820), quality management systems, and relevant industry experience, often supported by a degree in science, engineering, or a related field. Familiarity with auditing software, remote communication tools, and recognized auditor certifications (like IRCA or ASQ) is typically required. Strong attention to detail, analytical thinking, and effective communication are essential soft skills for evaluating compliance and collaborating with client teams remotely. These competencies ensure thorough, accurate audits and help organizations maintain regulatory compliance and uphold product safety standards.

What are common challenges faced by remote medical device auditors, and how can they be managed?

Remote Medical Device Auditors often face challenges such as ensuring thorough compliance assessments without on-site access and effectively communicating with diverse client teams across different time zones. To manage these challenges, auditors leverage robust virtual collaboration tools, detailed documentation, and clear communication protocols. Staying up to date with evolving regulatory standards and maintaining strong organizational skills are also critical for success in this role. Proactive planning and flexibility help auditors adapt to varied client needs and maintain audit quality remotely.

What are the most commonly searched types of Medical Device Auditor jobs in California?

The most popular types of Medical Device Auditor jobs in California are:

What are popular job titles related to Remote Medical Device Auditor jobs in California?

For Remote Medical Device Auditor jobs in California, the most frequently searched job titles are:

What job categories do people searching Remote Medical Device Auditor jobs in California look for?

The top searched job categories for Remote Medical Device Auditor jobs in California are:

What cities in California are hiring for Remote Medical Device Auditor jobs?

Cities in California with the most Remote Medical Device Auditor job openings:

Remote Medical Device Auditor jobs near you
Infographic showing various Remote Medical Device Auditor job openings in California as of August 2026, with employment types broken down into 90% Full Time, 6% Part Time, and 4% Contract. Highlights an 100% Remote job distribution.

Manager, Supplier & Internal Auditor

Vaxcyte

San Carlos, CA • On-site, Remote

$151K - $176K/yr

Full-time

Posted 17 days ago

Job description

Summary:

Vaxcyte is seeking a Manager Supplier & Internal Auditor to support the Quality Assurance organization through the planning, execution, and management of supplier and internal audits. This role will be responsible for assessing compliance with applicable global regulations, industry standards, and internal quality systems to ensure the integrity of Vaxcyte's operations and external partnerships. The ideal candidate is a certified auditor with strong working knowledge of GMP, GLP, GCP, ICH, and ISO 13485 requirements and experience auditing within the pharmaceutical, biotechnology, or medical device industries.

Essential Functions:

  • Supplier Audits
    • Plan, schedule, and conduct supplier audits (on-site and remote) in support of supplier qualification and ongoing oversight programs.
    • Evaluate supplier compliance with applicable regulations, standards, and contractual quality requirements.
    • Prepare audit agendas, audit reports, and documentation in accordance with internal procedures and regulatory expectations.
    • Review and assess supplier responses to audit observations, including corrective and preventive action (CAPA) plans, and verify effectiveness.
    • Collaborate with cross-functional stakeholders (e.g., Technical Operations, Supply Chain, Regulatory, Quality Systems) to assess audit findings and risk.
  • Internal Audits
    • Execute internal audits of quality systems and operational processes to assess compliance with GMP, GLP, GCP, ICH, ISO 13485, and internal policies and procedures.
    • Support the development and maintenance of the internal audit program, including risk-based audit planning and scheduling.
    • Identify compliance gaps, trends, and opportunities for continuous improvement.
    • Document audit observations clearly and objectively and support follow-up activities to ensure timely and effective remediation.
  • Compliance & Quality Systems
    • Ensure audit activities are conducted in accordance with applicable regulatory requirements and industry best practices.
    • Support inspection readiness by maintaining audit documentation and providing audit support during regulatory inspections as needed.
    • Contribute to the development, review, and improvement of quality procedures related to auditing, supplier management, and compliance.
    • Provide guidance and training to internal stakeholders on audit processes, regulatory expectations, and compliance requirements.

Requirements:

  • Bachelor's degree in Life Sciences or a related field.
  • 5+ years of experience in Quality Assurance, auditing, or compliance within the pharmaceutical, biotechnology, or medical device industry. Other combinations of education and/or experience may be considered.
  • Vaccine experience is preferred.
  • Current auditor certification (e.g., ASQ Certified Quality Auditor (CQA) or equivalent).
  • Strong working knowledge of GMP, GLP, GCP, ICH guidelines, and ISO 13485 requirements.
  • Demonstrated experience conducting supplier and/or internal audits.
  • Strong written and verbal communication skills, with the ability to clearly document audit observations and communicate risk.
  • Excellent organizational skills, attention to detail, and ability to manage multiple audits and priorities.
  • Ability to work independently while collaborating effectively in a cross-functional environment.
  • Ability to travel.

Reports to: Director, Quality Assurance, Vendor Management

Location: Hybrid in San Carlos, CA; Open to remote

Work Arrangement (may be adjusted based on business needs, job responsibilities, or changes to company policy): Hybrid (minimum of 3 days per week onsite)/Open to Remote

Compensation: The compensation package will be competitive and includes comprehensive benefits and an equity component.

Salary Range: $151,000 - $176,000 (SF Bay Area). Salary ranges for non-California locations may vary.

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About Vaxcyte

Sourced by ZipRecruiter

Industry

Biotechnology research and development

Company size

51 - 200 Employees

Headquarters location

San Carlos, CA, US

Year founded

2013

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