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Director Medical Device Quality Assurance Jobs (NOW HIRING)

Caraballo Consulting & Associates L

Be Seen First

QA Manufacturing Engineer - Medical Device

Sterling, VA · On-site

$40 - $80/hr

Experience in the medical device industry within Quality Assurance, Validation, Manufacturing Quality, or a closely related function. * Strong working knowledge of process validation, equipment ...

Caraballo Consulting & Associates L

Be Seen First

QA Manufacturing Engineer - Medical Device

Sterling, VA · On-site

$40 - $80/hr

Experience in the medical device industry within Quality Assurance, Validation, Manufacturing Quality, or a closely related function. * Strong working knowledge of process validation, equipment ...

B. Braun Group

VP, QA Franchise (Med Device)

Allentown, PA · On-site

$260K - $290K/yr

VP, QA Franchise (Med Device) Company: B. BRAUN MEDICAL (US) INC Job Posting Location: Allentown, Pennsylvania, United States Functional Area: Quality Working Model: Hybrid Days of Work: Wednesday ...

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 ... As a member of the Quality Assurance team, you will support activities that help Enovis drive the ...

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 ... As a member of the Quality Assurance team, you will support activities that help Enovis drive the ...

Ketryx

QA/RA Consultant

Boston, MA · On-site +1

$130K - $150K/yr

Job Title: QA/RA Consultant Employment Status: Full-time Office Hours: Monday - Friday; hybrid ... About You: You're a proven QMS expert who's successfully navigated complex medical device ...

MRINetwork Jobs

Quality Assurance Manager

Itasca, IL · On-site

... other relevant medical device standards. ● Develop, implement, and maintain quality system ... Direct experience managing CAPA, complaints, post-market surveillance systems, and MDR/adverse ...

MRINetwork Jobs

Quality Assurance Manager

Itasca, IL · On-site

... other relevant medical device standards. ● Develop, implement, and maintain quality system ... Direct experience managing CAPA, complaints, post-market surveillance systems, and MDR/adverse ...

MRINetwork Jobs

Quality Assurance Manager

Itasca, IL · On-site

... other relevant medical device standards. ● Develop, implement, and maintain quality system ... Direct experience managing CAPA, complaints, post-market surveillance systems, and MDR/adverse ...

Ketryx

QA/RA Consultant

Boston, MA · On-site

$130K - $150K/yr

You've built or significantly improved quality systems at medical device companies, consulting firms, or high-growth startups, and you're excited to combine your regulatory expertise with AI-powered ...

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Director Medical Device Quality Assurance information

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$56.5K

$140.1K

$227.5K

How much do director medical device quality assurance jobs pay per year?

As of Aug 27, 2026, the average yearly pay for director medical device quality assurance in the United States is $140,083.00, according to ZipRecruiter salary data. Most workers in this role earn between $103,000.00 and $169,000.00 per year, depending on experience, location, and employer.

What does a director of medical device quality assurance do?

A Director of Medical Device Quality Assurance oversees the quality management systems and regulatory compliance for medical device manufacturing and development. They ensure that products meet all applicable safety standards, regulations, and company quality requirements throughout the entire product lifecycle. This role involves leading quality assurance teams, coordinating audits, and working closely with other departments to implement best practices and continuous improvements. They also play a key role in responding to regulatory inspections and addressing any issues that could affect product quality or patient safety.

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

To excel as a Director of Medical Device Quality Assurance, you need deep expertise in quality management systems (QMS), regulatory compliance (such as FDA, ISO 13485), and a relevant science or engineering degree. Familiarity with risk management tools, CAPA systems, and regulatory submission platforms is typically required, alongside certifications like ASQ CQE or RAC. Strong leadership, strategic thinking, and effective communication are crucial soft skills for managing teams and cross-functional projects. These competencies ensure product safety, regulatory approval, and the overall success of the organization in a highly regulated industry.

How does a director of medical device quality assurance typically collaborate with cross-functional teams to ensure compliance and product quality?

A Director of Medical Device Quality Assurance works closely with teams such as R&D, regulatory affairs, manufacturing, and supply chain to ensure products meet both regulatory and company standards. This collaboration often includes leading quality audits, reviewing design and manufacturing processes, and facilitating risk assessments. Directors also coordinate regular meetings and training to align teams on quality objectives, address issues proactively, and ensure timely resolution of non-conformances. Effective communication and partnership across departments are essential for maintaining compliance and driving continuous improvement.

What is the difference between Director Medical Device Quality Assurance vs Quality Assurance Manager in the medical device industry?

AspectDirector Medical Device Quality AssuranceQuality Assurance Manager
CredentialsTypically requires a bachelor’s or master’s in life sciences, engineering, or related field; certifications like RAC or ISO auditor are commonSimilar educational background; certifications like ISO auditor or Six Sigma are often preferred
Work EnvironmentOversees multiple teams, strategic planning, and compliance at a higher levelManages daily quality assurance operations and team activities
Industry UsageUsed across medical device companies for leadership roles in quality assuranceCommonly used for operational quality roles within medical device companies

The main difference is that the Director Medical Device Quality Assurance focuses on strategic oversight and leadership, while the Quality Assurance Manager handles day-to-day quality operations. Both roles require similar credentials and work within the same industry environment, but the director position involves broader responsibilities and higher-level decision-making.

More about Director Medical Device Quality Assurance jobs

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Director Medical Device Quality Assurance jobs near you
Infographic showing various Director Medical Device Quality Assurance 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 $140,083 per year, or $67.3 per hour.

Medical Device Quality Inspector

Stellar IT Group

Madison, WI • On-site

Full-time

Re-posted 22 days ago

Job description

Overview:
Medical Device Quality Inspector
Madison, WI (Onsite)
6+ Months
Responsible for assuring that materials, activities, processes, and specified conditions related to the daily device manufacturing, processing and packaging meet current GMP standards and comply with applicable procedures and standards such as ensuring the quality integrity of the product. Ensure work is completed in compliance with the company quality system and medical device regulations. Ensure work is completed in compliance with the company quality system and medical device regulations.
Essential Functions
• Performs one of three functions in the Quality department:
o Inspecting raw materials to meet production requirements
o Conducts in-process inspection of manufacturing product and processes
o Reviews final documentation and shipment packaging for medical devices, subassemblies, and kits
• Assists in the Madison Manufacturing documentation control room.
• Completes documentation of activities performed, prepares and attaches material quality status labeling. Ensures storage and handling of product and labeling in a controlled and secure manner.
• Supports Quality through occasional conduct of investigations of nonconformance, assists with preventive actions associated with the QA unit.
• Performs quality reviews for quarantine releases on non-reportable, non-complaint, RMF-3 internal to an RSC.
Minimum Requirements
Education / Experience / Skills:
• High School diploma or equivalent
• One year's experience in a regulated work environment preferred
• Knowledge of FDA Quality System Regulations and ISO13485 pertaining to medical device manufacturing
Competencies:
• High Level of motivation; ability to work independently
• Detailed oriented
• Ability to work with computer-based systems daily
• Collaborator with strong levels of engagement with individuals and as a team member
• Good interpersonal skills; ability to communicate well, both verbally and written
Organizational Relationship/Scope:
Reports to the Quality Control Manager. This position is accountable for delivery of prompt investigative work and detailed reporting. Working across multiple functions, this position collaborates primarily with manufacturing, engineering and quality to assess nonconforming product and support supplier quality issues.
Working Conditions:
Manufacturing facility of medical devices and accessories. Controlled environmental working conditions.
Skills:
QUALITY,Medical Devices

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