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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 ...

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 ...

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 ...

Merck & Co.

$142K - $224K/yr

Required Qualifications and Skills:5 or more years relevant experience in quality assurance in a medical device or medical device combination product manufacturing organization.Bachelor's degree in ...

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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 29, 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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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 Systems & FDA Inspection Readiness Consultant

The FDA Group

Atlanta, GA

Full-time

Posted 2 days ago

New

Job description

Medical Device Quality Systems & FDA Inspection Readiness Consultant

Location: Atlanta/Duluth, Georgia area
Work Arrangement: Onsite
Duration: Immediate start through November 2026, with potential extension
Start: Immediate

Position Overview

We are seeking an experienced Medical Device Quality Systems Consultant to provide hands-on support for the startup of a new Class I medical device contract manufacturing operation.

The consultant will support Quality Management System (QMS) implementation, development of auditable quality and operational processes, system validation, and FDA inspection readiness. A key focus will be ensuring appropriate controls are established across production, warehousing, inventory, traceability, product hold/quarantine, release, and direct-to-consumer distribution activities.

The engagement will require both quality systems expertise and practical implementation support as the organization works toward regulatory and operational milestones in October and a planned November 1 go-live. The consultant may also provide training and ongoing Quality support following launch.

Key Responsibilities

  • Review the existing QMS and tailor requirements and processes for the new medical device manufacturing operation.

  • Support implementation of the QMS and ensure processes are operational, documented, and auditable.

  • Develop new quality and operational processes needed to support manufacturing and distribution activities.

  • Support validation of the warehouse management system and associated workflows.

  • Establish and/or assess controls for production, inventory management, product traceability, quarantine/hold, and product release.

  • Develop appropriate quality checks and controls for direct-to-consumer product shipments.

  • Assess Quality System and operational readiness for an anticipated FDA inspection.

  • Identify inspection-readiness gaps and support implementation of corrective actions before go-live.

  • Work directly with facility personnel to operationalize new procedures and quality controls.

  • Provide employee training and implementation support for new or revised processes, as needed.

  • Support the organization through its planned November 1 launch and provide ongoing Quality support following go-live, as needed.

Required Qualifications

  • Significant medical device Quality or Quality Systems experience.

  • Demonstrated experience implementing or adapting a QMS for medical device operations.

  • Strong knowledge of FDA medical device quality requirements and inspection readiness.

  • Experience developing and implementing auditable quality and operational processes.

  • Experience with warehouse, distribution, inventory, traceability, quarantine/hold, and product release controls.

  • Experience supporting computerized system validation or validation of warehouse/inventory management systems.

  • Ability to provide hands-on implementation support and work directly with site personnel.

  • Ability to work onsite in the Atlanta/Duluth, Georgia area.

Preferred Qualifications

  • Experience supporting startup or launch activities for a medical device manufacturing operation.

  • Experience with Class I medical devices.

  • Experience establishing quality controls for direct-to-consumer distribution.

  • Local to the Atlanta/Duluth, Georgia area.

Work Arrangement

This engagement requires onsite support in the Atlanta/Duluth, Georgia area. Local consultants are preferred to facilitate consistent onsite support.

Ideal Candidate

The ideal consultant is a hands-on Medical Device Quality Systems professional with experience taking QMS requirements from documented procedures through practical implementation. The consultant should be comfortable working across quality systems, warehouse and distribution controls, system validation, and FDA inspection readiness while helping a new manufacturing operation prepare for launch.