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Iso 14971 Jobs (NOW HIRING)

Lubrizol Corporation

Senior Quality Engineer

Corona, CA

$91K - $123K/yr

Coordinate and facilitate risk management activities in accordance with ISO 14971, including hazard analysis, risk assessments, and mitigation activities. * Lead development and maintenance of ...

Lubrizol Corporation

Senior Quality Engineer

Corona, CA · On-site

$135 - $145/hr

Coordinate and facilitate risk management activities in accordance with ISO 14971, including hazard analysis, risk assessments, and mitigation activities. * Lead development and maintenance of ...

Epia Neuro

Senior Quality Engineer

Alameda, CA · On-site

$120 - $180/hr

You'll bring hands-on software quality engineering experience to support our software and firmware teams in meeting IEC 62304, ISO 14971, and ISO 13485/FDA QMSR requirements throughout the product ...

Adecco

Senior Quality Engineer

Devens, MA

$100K - $120K/yr

Oversee Design History Files (DHF), design verifications, and risk management files per ISO 14971. * Process Validation: Lead and approve IQ/OQ/PQ manufacturing validations, test methods, and ...

Elucent Medical

Director of Quality

Eden Prairie, MN · On-site

$155K - $170K/yr

Responsibilities include QMS implementation and continuous improvement in accordance with 21 CFR Part 820, ISO 13485, ISO 14971, and applicable global standards, as well as product quality leadership ...

Jobtailor

Senior Engineer, Design Quality

San Clemente, CA · On-site

$110 - $170/hr

Experience with ISO and FDA QSR regulations, including ISO 13485 and ISO 14971 * Knowledge of Quality Management Systems and experience linking risk management to Design Controls, CAPA, Complaints ...

LifeNet Health

Quality Engineer I

Virginia Beach, VA

$64K - $83K/yr

Ensure compliance with applicable regulatory and quality system requirements including 21 CFR Part 820, ISO 13485, and ISO 14971 across product and process activities. * Provide Quality Engineering ...

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Iso 14971 information

What is ISO 14971?

ISO 14971 is an international standard that outlines the requirements for risk management in the design and production of medical devices. It provides a systematic process for identifying, evaluating, and controlling risks to ensure the safety of patients, users, and others involved with medical devices. Compliance with ISO 14971 is often required by regulatory bodies and helps manufacturers demonstrate that they have taken appropriate steps to minimize potential hazards associated with their products.

What are the common challenges faced by professionals implementing ISO 14971 in medical device companies?

One of the main challenges in implementing ISO 14971 is ensuring cross-functional collaboration between engineering, quality assurance, regulatory, and clinical teams to comprehensively identify and manage risks throughout the product lifecycle. Professionals often face the task of translating complex technical data into clear risk management documentation that meets regulatory expectations. Keeping up with evolving regulations and maintaining consistent risk management practices across multiple projects can also be demanding. Effective communication and ongoing training are essential to successfully embed ISO 14971 processes into everyday operations.

What are the key skills and qualifications needed to thrive as an ISO 14971 risk management specialist, and why are they important?

To thrive as an ISO 14971 Risk Management Specialist, you need a strong understanding of risk management principles, regulatory standards for medical devices, and a relevant science or engineering background. Experience with risk assessment tools, quality management systems (such as ISO 13485), and familiarity with documentation software are typically required. Excellent analytical thinking, attention to detail, and effective communication skills set top performers apart in this role. These capabilities are critical to ensuring compliance, patient safety, and the successful commercialization of medical devices.

What is the difference between Iso 14971 vs Medical Device Quality Engineer?

AspectIso 14971Medical Device Quality Engineer
CertificationsISO 14971 certification, risk management trainingISO 13485, Six Sigma, quality management certifications
Work EnvironmentRegulatory compliance, risk assessment in medical device developmentQuality assurance, process improvement, audits in medical device manufacturing
Industry UsageUsed by regulatory professionals and risk managersUsed by quality assurance and engineering teams

While Iso 14971 focuses on risk management standards for medical devices, a Medical Device Quality Engineer ensures overall product quality and compliance. Both roles are essential in the medical device industry but serve different functions—one emphasizes risk assessment, the other quality assurance.

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Iso 14971 jobs near you
Infographic showing various Iso 14971 job openings in the United States as of August 2026, with employment types broken down into 91% Full Time, 2% Part Time, 5% Contract, and 2% Nights. Highlights an 89% Physical, 4% Hybrid, and 7% Remote job distribution.

Medical Device Risk Management Advisor (Part-Time, Remote)

FocusKPI Inc.

Remote

Other

Re-posted yesterday

Job description

We are building an AI-powered platform to support medical device risk management and regulatory documentation (including ISO 14971 and design controls), and are looking for a few professionals to serve as ongoing product feedback advisors.

This is a flexible, part-time opportunity for experienced professionals who can periodically test new features, review workflows, and provide practical feedback based on real-world medical device and regulatory experience. Your input will directly shape how the product supports day-to-day work in regulated environments.

What You’ll Do

  • Test new features and prototypes periodically

  • Provide feedback on usability and regulatory alignment

  • Review risk management and documentation workflows

  • Suggest improvements based on real industry practice

  • Join occasional 30–45 minute feedback sessions

Time Commitment

  • Flexible, ongoing engagement

  • Approximately 1–2 hours per week or biweekly

  • Fully remote

Preferred Background

  • Medical device regulatory affairs or quality assurance

  • Experience with ISO 14971 risk management

  • Design controls / DHF documentation

  • 510(k), De Novo, or PMA experience is a plus

  • Risk management file, FMEA, or hazard analysis experience

Consultants and industry professionals are welcome.

How to Apply

If you’re interested, please complete this short screening form so we can better understand your background:

https://forms.gle/jgj1ZN2jtAGGAbYQA

We’ll follow up with selected candidates to schedule an initial session and discuss next steps.

NOTICE: Please be aware of fraudulent emails regarding job postings, job offers and fake checks. FocusKPI's recruiting team will strictly reach out via @focuskpi.com email domain. If you have received fraudulent emails now or in the past, please report it to https://reportfraud.ftc.gov/ . The domain @focuskpijobs.com is fraudulent and not related to FocusKPI. Please do not not reply or communicate to anyone with @focuskpijobs.com.

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About FocusKPI

Sourced by ZipRecruiter

Industry

Computing infrastructure providers, data processing, web hosting

Company size

51 - 200 Employees

Headquarters location

Santa Clara, CA, US

Year founded

2010

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