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Quality Director Medical Device Jobs (NOW HIRING)

Kellton Tech

Medical Device Assembler

Madison, WI · On-site

$23 - $24/hr

Ensure work is completed in compliance with company quality system and medical device regulations ... Self-directed Teamwork Good communication skills Proficient with computer systems Critical thinking ...

Excel Medical Products

Medical Device Assembly

Wixom, MI · On-site

$16 - $17/hr

Document production activities, lot traceability, and quality records per FDA and ISO regulations ... Prior experience in medical device assembly, electronics assembly, or precision manufacturing ...

Excel Medical Products

Medical Device Assembly

Wixom, MI · On-site

$16 - $17/hr

Document production activities, lot traceability, and quality records per FDA and ISO regulations ... Prior experience in medical device assembly, electronics assembly, or precision manufacturing ...

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 ...

AstrixTechnology LLC

Be Seen First

Medical Device Assembler

Santa Rosa, CA · On-site

$20 - $25/hr

Pay: $22-25/hour Position Summary The Medical Device Assembly Technician is responsible for assembling high-quality medical devices in accordance with approved manufacturing processes, work ...

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$31K

$125.6K

$213.5K

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

As of Aug 26, 2026, the average yearly pay for quality director medical device in the United States is $125,600.00, according to ZipRecruiter salary data. Most workers in this role earn between $91,000.00 and $151,000.00 per year, depending on experience, location, and employer.

What does a quality director do in the medical device industry?

A Quality Director in the medical device industry is responsible for overseeing the development, implementation, and maintenance of quality management systems to ensure products meet regulatory and industry standards. They lead quality assurance teams, manage compliance with FDA and international regulations, and drive continuous improvement initiatives. Their work helps guarantee that medical devices are safe, effective, and reliable for patients and healthcare providers.

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

To thrive as a Quality Director in the Medical Device industry, you need deep expertise in quality management systems (such as ISO 13485), regulatory compliance (FDA, EU MDR), and a background in engineering or life sciences. Familiarity with risk management tools, CAPA systems, and regulatory submission processes, along with certifications like ASQ CQE or Six Sigma, is highly valued. Strong leadership, problem-solving, and communication skills are essential for managing teams and fostering a culture of quality. These skills and qualifications are crucial to ensuring product safety, regulatory approval, and continuous improvement within highly regulated environments.

What are some common challenges a quality director faces in the medical device industry, and how can they be addressed?

A Quality Director in the medical device industry often encounters challenges such as navigating complex regulatory requirements, maintaining compliance across global markets, and ensuring consistent product quality during rapid growth or innovation. Proactive communication with cross-functional teams, continuous training on evolving standards like ISO 13485 and FDA regulations, and implementing robust quality management systems are key strategies to address these challenges. Building a culture of quality and fostering close collaboration between departments like R&D, manufacturing, and regulatory affairs are also essential for success in this role.

What is the role of a Quality Director Medical Device?

A Quality Director in the medical device industry oversees the development and implementation of quality management systems to ensure products meet regulatory standards and safety requirements. They lead quality assurance teams, conduct audits, and collaborate with regulatory bodies, often requiring knowledge of ISO 13485 and FDA regulations. Their role is critical in maintaining product compliance and continuous improvement processes.
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Quality Director Medical Device jobs near you
Infographic showing various Quality Director Medical Device 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 $125,600 per year, or $60.4 per hour.

Quality Director (Medical Device / USCT)

Remote

Midjourney
Scientific Research and Development Services • 11 - 50 employees
Learn more about Midjourneyexternal

Full-time

Posted 14 days ago

Job description

What you'll do
  1. Own and evolve the Quality Management System (QMS) to support a regulated medical device development program, including design controls and DHF maintenance.
  2. Establish and enforce requirements traceability: user needs → design requirements → verification/validation artifacts and change control.
  3. Define and run the program-level V&V strategy (verification, validation, and test coverage), including test plans, protocols, reports, and acceptance criteria.
  4. Drive risk management activities (e.g., DFMEA / PFMEA, hazard analyses) and ensure mitigations are reflected in requirements and verification.
  5. Lead document control: reviews, approvals, training, retention, and audit readiness.
  6. Partner with engineering to make quality "native" to the dev workflow (automated testing, release gates, software configuration management).
  7. Prepare the program for audits and inspections, including hands-on audit leadership.
What we're looking for
  • Senior experience leading quality for complex hardware + software products in a regulated environment.
  • Deep familiarity with design controls, DHF, document control, risk management, and verification planning.
  • Strong systems thinking and the ability to translate ambiguous product intent into testable requirements.
  • Comfortable collaborating directly with multidisciplinary engineering (recon/ML, embedded, mechanical, EE, cloud).
Useful experience
  • Regulated product quality leadership (ISO 13485 / 21 CFR 820 or equivalent), including audit readiness and FDA-facing work.
  • eQMS + document control fluency (e.g., Greenlight Guru) that integrates cleanly with modern engineering workflows.

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