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Iso 13485 Jobs (NOW HIRING)

Ott Scientific

Quality Control Analyst I

Warrington, PA · On-site

$59K - $69K/yr

At least one (1) year of experience working in an ISO 13485 or FDA GMP regulated environment preferred. * At least one (1) year of experience working in an ISO 13485 or FDA GMP regulated environment ...

Intellectt INC

Validation Engineer

San Diego, CA · On-site

The role focuses on developing high-quality validation documentation, executing validation protocols, ensuring compliance with FDA, ISO 13485, ISO 14971, cGMP, and procedures, and supporting ...

Natera

Quality Engineer

Austin, TX · Hybrid

$71K - $92K/yr

Support internal and external audits (CLIA/CAP, ISO 13485, customer) * Responsible for CAPA, Deviation, Change Requests and Nonconformance investigation and reporting * Write/revise procedures and ...

Polysciences, Inc.

Quality Control Analyst I

Warrington, PA · On-site

$23.50 - $31.75/hr

At least one (1) year of experience working in an ISO 13485 or FDA GMP regulated environment preferred. * At least one (1) year of experience working in an ISO 13485 or FDA GMP regulated environment ...

Siri InfoSolutions Inc

Electrical Engineer

Blue Ash, OH · On-site

Medical Standards Compliance - IEC 60601, ISO 13485, FDA 21 CFR Part 820. Failure Analysis - Root cause analysis (FMEA, 5 Whys, Fishbone). · Verification & Validation - Test planning, execution, and ...

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How much do iso 13485 jobs pay per hour?

As of Aug 6, 2026, the average hourly pay for iso 13485 in the United States is $21.09, according to ZipRecruiter salary data. Most workers in this role earn between $18.27 and $21.63 per hour, depending on experience, location, and employer.

What are the typical day-to-day responsibilities of someone working in an ISO 13485 quality assurance role?

Professionals in an ISO 13485 quality assurance role are typically responsible for developing, implementing, and maintaining quality management systems specific to medical devices. Their daily tasks include preparing documentation, conducting internal audits, ensuring compliance with regulatory standards, managing nonconformances, and coordinating corrective actions. They often collaborate closely with engineering, manufacturing, and regulatory affairs teams to address quality issues and facilitate continuous improvement. This position involves significant attention to detail and communication to uphold the organization’s quality objectives and regulatory commitments.

What is an ISO 13485?

An ISO 13485 job typically involves roles in quality management, regulatory compliance, and manufacturing within the medical device industry. Professionals in these roles ensure that companies adhere to ISO 13485, the international standard for quality management systems in medical devices. Responsibilities may include managing audits, maintaining documentation, overseeing regulatory compliance, and improving quality processes. These jobs are crucial for ensuring product safety, consistency, and compliance with regulatory requirements.

What are the key skills and qualifications needed to thrive in the ISO 13485 position, and why are they important?

To thrive in an ISO 13485 role, you need a strong understanding of quality management systems for medical devices, regulatory requirements, and risk management principles, often supported by a background in engineering, life sciences, or quality assurance. Familiarity with audit processes, CAPA (Corrective and Preventive Action) systems, and certifications like Certified Quality Auditor (CQA) or ISO 13485 Lead Auditor are highly valued. Attention to detail, problem-solving abilities, and effective communication set outstanding candidates apart. These skills ensure compliance with stringent regulations and help maintain product quality and patient safety in the medical device industry.

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Iso 13485 jobs near you
Infographic showing various Iso 13485 job openings in the United States as of August 2026, with employment types broken down into 80% Full Time, and 20% Contract. Highlights an 80% In-person, and 20% Remote job distribution, with an average salary of $43,861 per year, or $21.1 per hour.

Quality Assurance Specialist II

Alphatec Spine

Carlsbad, CA

Full-time

Posted 17 days ago

Job description

The primary responsibility of the Quality Assurance Specialist II includes supporting ATEC's quality system in compliance with ISO 13485, 21CFR820 and MDSAP. This position will ensure that auditing activities to maintain compliance, and support Document Control and Compliance Departments. This role supports the development and operation of the Quality Management System (QMS) at Alphatec Spine. This position also supports compliance to applicable domestic and international regulatory medical device regulations such as Part 820, 1271, MDD 93/42/EEC, ISO 13485:2003, Australian Therapeutic Goods (TGA), Japan (MHLW/PMDA).

Essential Duties and Responsibilities

  • Assist in the establish of systems to assure compliance with domestic (21CFR820) and international regulations (Australia: Australian Therapeutic Goods Administration, Japan: MHLW/PMDA
  • Assist in implementation of changes for QMS procedures and policies to ensure compliance to ISO 13485 and specific country requirements. Partners with appropriate stakeholders to define, recommend and implement QMS process improvements.
  • Plans and coordinates quality/compliance activities, identify roadblocks, and strategizes on various compliance paths for new products.
  • Review documents to ensure regulatory compliance
  • Designs, implements and maintains the quality systems ensuring compliance requirements
  • Supports internal QMS audits as needed for compliance.
  • Assists with Health Hazard Evaluations (HHE) with cross functional team members.
  • Facilitates CAPAs as needed to ensure compliance along with timeliness of completion.
  • Supports development of key QMS metrics. Provides analysis and reporting for Monthly Trend and Management Review Meetings.
  • Assist the complaint handling system in accordance with domestic and international regulatory requirements, as needed.
  • Performs other duties as assigned or required.

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