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Biocompatibility Jobs in California (NOW HIRING)

Inquis Medical, Inc.

Quality Manager

San Francisco, CA

$145K - $165K/yr

Provide support and guidance to biocompatibility and environmental control programs. * Review and approve all product labeling and marketing materials to ensure compliance with regulatory ...

New

Capstan Medical, Inc.

Quality Engineer

Santa Cruz, CA

$83K - $107K/yr

Collaborate with R&D and Regulatory Affairs teams to ensure that biocompatibility requirements are met for medical devices. * Provide guidance on sterilization processes and validations to ensure ...

Capstan Medical, Inc.

Quality Engineer

Santa Cruz, CA · On-site

$83K - $107K/yr

Collaborate with R&D and Regulatory Affairs teams to ensure that biocompatibility requirements are met for medical devices. * Provide guidance on sterilization processes and validations to ensure ...

Capstan Medical, Inc.

Quality Engineer

Santa Cruz, CA · On-site

$83K - $107K/yr

Collaborate with R&D and Regulatory Affairs teams to ensure that biocompatibility requirements are met for medical devices. * Provide guidance on sterilization processes and validations to ensure ...

Inquis Medical, Inc.

Quality Manager

Menlo Park, CA

$145K - $165K/yr

Provide support and guidance to biocompatibility and environmental control programs. * Review and approve all product labeling and marketing materials to ensure compliance with regulatory ...

New

SaniSure LLC

Supplier Quality Engineer

Camarillo, CA · On-site

$95K - $105K/yr

Ensure compliance with biocompatibility, material, and regulatory requirements. * Support regulatory submissions requiring supplier documentation. Risk Management * Participate in supplier risk ...

MatrixCare

Senior Moulding Engineer (Onsite)

Calabasas, CA · On-site

$110K - $152K/yr

Selects and justifies resin or LSR based on shrinkage, rheology, cure, and biocompatibility requirements; anticipates material-related defects. Tooling & DFM:Reviews mold designs for gating, venting ...

New

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Biocompatibility information

What is a biocompatibility job?

A Biocompatibility job involves evaluating medical devices, materials, and implants to ensure they are safe and non-toxic for human use. Professionals in this role analyze the interactions between biomaterials and biological systems, conducting risk assessments and regulatory compliance reviews. They work closely with engineers, scientists, and regulatory teams to meet standards like ISO 10993. This job is critical in ensuring patient safety and securing product approvals for medical devices.

What are the typical daily responsibilities in biocompatibility?

Professionals in Biocompatibility routinely assess the biological safety of new materials or devices, design or coordinate laboratory tests, and analyze results to determine compliance with regulatory standards. Their day-to-day work often involves preparing technical reports, collaborating with R&D and regulatory teams, and communicating findings to project stakeholders. You may also contribute to risk assessments, provide input during product development stages, and stay updated on evolving international regulations. This role requires balancing technical expertise with proactive communication to ensure the safe and timely approval of medical products.

What are the key skills and qualifications needed for biocompatibility?

To thrive in a Biocompatibility role, you typically need a background in biomedical engineering, materials science, or a related life science field, with strong knowledge of biological safety and regulatory requirements for medical devices. Familiarity with ISO 10993 standards, biocompatibility testing methods, and data analysis tools is essential, along with potential certification in regulatory affairs or toxicology. Attention to detail, effective communication, and problem-solving abilities are vital soft skills for collaborating across multidisciplinary teams. These skills ensure accurate safety evaluations and regulatory compliance, which are crucial for bringing safe and effective medical products to market.

What are the most commonly searched types of Biocompatibility jobs in California?

The most popular types of Biocompatibility jobs in California are:

What are popular job titles related to Biocompatibility jobs in California?

For Biocompatibility jobs in California, the most frequently searched job titles are:

What job categories do people searching Biocompatibility jobs in California look for?

The top searched job categories for Biocompatibility jobs in California are:

What cities in California are hiring for Biocompatibility jobs?

Cities in California with the most Biocompatibility job openings:

Biocompatibility jobs near you
Infographic showing various Biocompatibility job openings in California as of August 2026, with employment types broken down into 96% Full Time, 1% Part Time, 1% Temporary, and 2% Contract. Highlights an 85% Physical, 4% Hybrid, and 11% Remote job distribution.

Quality Manager

Inquis Medical, Inc.

San Francisco, CA

$145K - $165K/yr

Full-time

Posted yesterday

New

Job description

This role is responsible for ensuring the company's quality system is and maintain compliance California FDB and US FDA QSR requirements. This position has the responsibility and authority to act independently from the rest of the organization on all matters affecting product quality and compliance. Specifically, this person may initiate action to prevent non-conformities; identify and document quality problems and initiate, recommend, provide and verify solutions to quality problems. This role may require deliverables from other departments to support FDA Quality Management System requirements; may issue Corrective/Preventive Action Requests to internal departments or suppliers as required; may initiate Supplier disqualification based on continued unsatisfactory performance.

Principal Responsibilities:

  • Establish and Maintain Quality Management System.
  • Maintain QMS Manual and associated procedures.
  • Review and interpret quality/regulatory compliance requirements and ensure that they are implemented through company policies and procedures.
  • Develop regulatory compliance and quality plans and strategies in concert with affected functional areas.
  • Prepare and/or review FDA and other regulatory applications and documents, including Medical Device License Applications and Medical Device Reports as required.
  • Review and approve all new and changed manufacturing processes to ensure compliance with requirements of FDA and FDB.
  • Provide support and guidance to biocompatibility and environmental control programs.
  • Review and approve all product labeling and marketing materials to ensure compliance with regulatory requirements.
  • Manage Document Change Control
  • Manage supplier quality management/audit program.
  • Manage internal quality audit program.
  • Manage Medical Device Reporting and complaint management activities.
  • Develop, implement and supervise the non-conformance (NCR) and CAPA systems.
  • Initiate and Chair Material Review Board (MRB) if/as required.
  • Ensure training on all released QMS procedures and quality records is current.
  • Ensure calibration system for all inspection, production and R&D instruments is established and maintained.

Education / Experience Requirements:

  • Four-year bachelor's degree required. Desired in an engineering field
  • Familiar with 21 CFR 820, 21 CFR Part 11, ISO 13485 and ISO 14971.
  • Experience in medical device start-ups preferred
  • Minimum 6 years quality experience in FDA regulated medical devices or related industry
  • Familiar with 21 CFR 820, 21 CFR Part 11, ISO 13485 and ISO 14971.
  • Experience in medical device start-ups
  • Experience in managing sterilization controls for a Class II or Class III sterile product (EO Preferred)
  • Working knowledge of current FDA Quality Systems Regulation and equivalent international requirements for medical devices.
  • Direct, recent involvement in 510k Submissions, IDE Submission, and/or CE mark filings (Desired)
Compensation Range
$145,000—$165,000 USD

Inquis Medical is an Equal Opportunity Employer and embraces diversity. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any characteristic protected by applicable law.

Inquis Medical does not accept resumes or candidate submissions from third-party recruiters and/or vendors who are not expressly under current written contract.