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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 ...

Enovis

Medical Device Quality Engineer

Austin, TX · On-site

$71K - $92K/yr

Medical Device Quality Engineer Reports To : Sr. Manager, Quality Engineering Location: Austin, TX Business Unit Description : As a member of the Quality Assurance team, you will support activities ...

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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 22, 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 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.

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 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 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.

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Cities with the most Medical Device Quality Consultant job openings:

What states have the most Medical Device Quality Consultant jobs?

States with the most job openings for Medical Device Quality Consultant jobs include:

What job categories do people searching Medical Device Quality Consultant jobs look for?

The top searched job categories for Medical Device Quality Consultant jobs are:

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, 77% Full Time, 15% Part Time, and 7% Contract. Highlights an 89% Physical, 1% Hybrid, and 10% Remote job distribution, with an average salary of $105,586 per year, or $50.8 per hour.

Medical Device Quality Remediation Consultants (Hybrid)

The FDA Group

Fort Worth, TX • On-site

Full-time, Part-time

Posted 2 days ago

New

Job description

Medical Device Quality Remediation Consultants

Location: North of Fort Worth, TX
Work Arrangement: Primarily Onsite / Hybrid Flexibility
Duration: Initial 3-month engagement with potential extension to 6+ months
Openings: 2 Consultants
Start: ASAP / Within the next few weeks
Schedule: Full-time preferred; qualified part-time consultants may also be considered

Position Overview

We are seeking two experienced Medical Device Quality Remediation Consultants to support a quality systems remediation initiative at a medical device organization in Texas.

The consultants will provide hands-on support addressing CAPA and complaint backlogs, FDA remediation activities, quality and regulatory records, and implementation of FDA Quality Management System Regulation (QMSR) requirements.

This engagement requires professionals who can move beyond high-level strategy and actively drive remediation activities through completion. The ideal consultants will be able to identify root causes, develop practical and sustainable corrective actions, and work collaboratively with site personnel to strengthen the overall Quality Management System.

Key Responsibilities

  • Drive investigation, remediation, and closure of open and aging CAPAs.
  • Address existing complaint-handling backlogs and support timely closure of complaint records.
  • Evaluate and improve complaint-handling processes to promote sustainable compliance.
  • Perform and/or support root-cause investigations and development of effective corrective actions.
  • Support remediation activities resulting from FDA inspection observations.
  • Assist with quality and regulatory record management and remediation.
  • Support implementation and integration of FDA QMSR requirements into the existing Quality Management System.
  • Ensure remediation activities align with applicable FDA requirements and ISO 13485.
  • Identify systemic quality issues and develop practical corrective actions that address underlying causes rather than short-term fixes.
  • Collaborate with Quality, Regulatory, Operations, and other cross-functional stakeholders to drive remediation activities to completion.

Required Qualifications

  • Significant medical device industry experience.
  • Strong working knowledge of ISO 13485.
  • Strong knowledge of 21 CFR Part 820 and FDA QMSR requirements.
  • Demonstrated hands-on experience with CAPA remediation and closure.
  • Strong complaint handling and complaint investigation experience.
  • Experience supporting remediation following FDA inspections and observations.
  • Experience with quality records and regulatory documentation.
  • Strong root-cause analysis, investigation, and problem-solving capabilities.
  • Ability to develop sustainable, compliant solutions and effectively drive them through implementation.
  • Comfortable working in a hands-on consulting environment with significant interaction with site personnel.

Work Arrangement

This engagement will require frequent onsite presence in Texas. Some administrative and documentation activities may be completed remotely when appropriate.

Local candidates are preferred; however, travel can be accommodated for highly qualified consultants who are not located in the area.

Ideal Candidate

The ideal consultant is a seasoned medical device Quality Systems/Remediation professional with substantial hands-on experience in CAPA, complaints, FDA remediation, ISO 13485, and FDA QMSR/21 CFR Part 820.