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Medical Device Quality Consultant Jobs (NOW HIRING)

Kellton Tech

Medical Device Quality Inspector

Madison, WI · On-site

$25 - $30/hr

Medical Device Quality Inspector Location: Madison, WI (Onsite) Pay Rate: $25-30/hr. on W2 **Opportunity to earn overtime pay** The Medical Device Quality Inspection group is responsible for assuring ...

Kellton Tech

Medical Device Quality Engineer

Madison, WI · On-site

$40 - $45/hr

Medical Device Quality Engineer Location: Madison, WI Pay Rate : $40--45/hr on W2 Schedule: Onsite, Monday-Friday (standard business hours) Summary The Senior Quality Analyst/Engineer is responsible ...

Saxon Global

QA ENGINEER

Saint Augustine, FL · On-site

Company Description Saxon Global is one of the fastest growing Inc 500 Companies in the US, providing enhanced IT consulting, and engineering solution services. Job Title :Medical Device Quality ...

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Medical Device Quality Consultant information

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How much do medical device quality consultant jobs pay per hour?

As of Aug 8, 2026, the average hourly pay for medical device quality consultant in the United States is $50.76, according to ZipRecruiter salary data. Most workers in this role earn between $36.54 and $67.07 per hour, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive as a medical device quality consultant?

To thrive as a Medical Device Quality Consultant, you need expertise in quality management systems (QMS), regulatory compliance (such as FDA and ISO 13485), and a relevant science or engineering degree. Familiarity with quality auditing tools, risk management software, and documentation systems is typically required, along with certifications like Certified Quality Auditor (CQA) or Six Sigma. Strong analytical thinking, attention to detail, and effective communication are crucial soft skills for collaborating with cross-functional teams and ensuring regulatory adherence. These skills and qualifications are essential to ensure medical devices meet stringent quality and safety standards, reducing risk for both companies and patients.

What is the difference between Medical Device Quality Consultant vs Medical Device Quality Specialist?

AspectMedical Device Quality ConsultantMedical Device Quality Specialist
CredentialsISO 13485 Lead Auditor, CQE, or similar certificationsISO 13485 Lead Auditor, CQE, or similar certifications
Work EnvironmentConsulting firms, client sites, project-basedIn-house or manufacturing facilities, ongoing roles
Employer & Industry UsageConsultants hired by companies for specific projectsCompanies' quality departments, manufacturing plants
Search & Comparison IntentSeeking external expertise, project-based workInternal quality management, compliance roles

The main difference is that Medical Device Quality Consultants provide external, project-based expertise to improve quality systems, while Medical Device Quality Specialists work internally within organizations to maintain ongoing quality compliance. Both roles require similar certifications but differ in work setting and scope.

What are some common challenges faced by medical device quality consultants when working with cross-functional teams?

Medical Device Quality Consultants often collaborate with teams from engineering, manufacturing, and regulatory affairs, which can present challenges such as aligning differing priorities and ensuring clear communication across departments. Navigating varying levels of quality system knowledge among stakeholders may also require additional training and support. Additionally, consultants must stay current with evolving global regulatory requirements to advise teams accurately and implement compliant processes effectively.

What does a medical device quality consultant do?

A Medical Device Quality Consultant assists companies in ensuring their medical devices comply with regulatory standards and quality management systems, such as ISO 13485 and FDA requirements. They help identify gaps in processes, develop quality documentation, and guide teams through audits and inspections. Their expertise helps organizations maintain product safety, effectiveness, and compliance throughout the product lifecycle.
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Medical Device Quality Consultant jobs near you
Infographic showing various Medical Device Quality Consultant job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 78% Full Time, 15% Part Time, and 6% Contract. Highlights an 91% Physical, 1% Hybrid, and 8% Remote job distribution, with an average salary of $105,586 per year, or $50.8 per hour.

Medical Device Quality Engineer

Prophecy Technologies

Santa Clara, CA • On-site

$84K - $109K/yr

Full-time

This job post has expired 1 day ago. Applications are no longer accepted.

Job description

Role Overview:
This role focuses on ensuring quality and compliance within the medical device industry, specifically for a surgical robotics platform. The engineer will be responsible for design transfer, production support, and maintaining the Quality Management System (QMS) in adherence to regulatory standards.
Key Responsibilities:
  • Lead design transfer and production support activities, ensuring compliance with FDA/ISO 13485 and alignment with manufacturing readiness.
  • Own multiple subassemblies for a surgical robotics platform, ensuring design integrity, quality, and manufacturability.
  • Investigate non-conformances (NCs) using root cause analysis and drive CAPA within the QMS framework.
  • Develop and maintain FMEAs, support risk mitigation, and lead manufacturing issue resolution and qualifications (IQ/OQ/PQ).
  • Identify and implement compliant, alternative solutions to engineering and production challenges while driving continuous improvement.
  • Support and maintain Quality Management System (QMS) processes in compliance with regulatory requirements.
  • Collaborate with cross-functional teams to deliver quality-compliant outcomes.
  • Interpret and apply medical device regulations and standards to projects and processes.
  • Support audits and regulatory inspections, ensuring timely closure of actions.

Required Skills:
  • Strong understanding of Medical Device Quality Systems and regulatory compliance requirements.
  • Working knowledge of ISO 13485:2016/2019 and 21 CFR Part 820 (FDA Quality System Regulation).
  • Strong expertise in design transfer activities, including DHF ? DMR transition and compliance with FDA 21 CFR 820 & ISO 13485.
  • Sound knowledge of Medical Device Regulations, including MDD and MDR.
  • Proven experience in Non-Conformance (NC) management, CAPA processes, and internal/external audits.
  • Expertise in Medical Device Risk Management, with the ability to identify both apparent and less-obvious risks.
  • Practical experience with Application, Process, Design, and System FMEA methodologies.
  • Proficient in statistical tools and techniques, including Design of Experiments (DOE).
  • Capable of performing advanced descriptive and non-parametric statistical analyses.
  • Experienced in leveraging advanced statistical methods for reliability prediction and data-driven decision making.
  • EIS: Medical Device & Regulations

Qualifications:
  • 8+ years of experience in Medical Device Quality & Compliance.
  • Strong knowledge of ISO 13485, 21 CFR 820, MDD/MDR.
  • Expertise in Design Transfer Activities.
  • Hands-on experience in QMS, NC, CAPA, and Audits.
  • Strong expertise in Risk Management (ISO 14971), including FMEA and data-driven quality decisions.

Preferred Skills:
  • EIS: MDD Risk Management

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