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Quality Engineer Medical Device Jobs in Texas (NOW HIRING)

Enovis

Sr. Quality Engineer - Enabling Technology

Austin, TX · On-site

$87K - $118K/yr

Knowledge and experience with software as a medical device. * Independently plan, develop,maintain ... ASQ Certified Quality Engineer (CQE), Six Sigma Green Belt/Black Belt, or equivalent certification.

Enovis

Sr. Quality Engineer - Enabling Technology

Austin, TX · On-site

$87K - $118K/yr

Knowledge and experience with software as a medical device. * Independently plan, develop, maintain ... ASQ Certified Quality Engineer (CQE), Six Sigma Green Belt/Black Belt, or equivalent certification.

Quest Medical, Inc.

Quality Engineer

Allen, TX · On-site

$67K - $86K/yr

Provide quality engineering support to engineering project teams associated with new product ... A minimum of 5 years' experience in the medical device manufacturing industry is preferred.

Steris Corporation

Senior Quality Engineer

Conroe, TX · On-site

$79K - $107K/yr

Position Summary The Senior Quality Engineer is responsible for managing processes and leading ... Experience with medical device or other regulated industries. * Quality Management System ...

Medivators Inc.

Senior Quality Engineer

Conroe, TX · On-site

$75K - $102K/yr

Position Summary The Senior Quality Engineer is responsible for managing processes and leading ... Experience with medical device or other regulated industries. * Quality Management System ...

Actalent

Quality Engineer

Plano, TX · On-site

$69K - $89K/yr

Quality Engineer The Quality Engineer plays a key role in ensuring robust manufacturing quality and regulatory compliance in an electronics and medical device environment. Approximately 60% of the ...

Medtronic

Quality Engineer II

Fort Worth, TX · On-site

$69K - $89K/yr

Join a world-class medical device manufacturing site in Fort Worth, Texas with Medtronic! As a Quality Engineer at Medtronic Fort Worth, you will work at the forefront of spine surgery medical device ...

Medtronic

Quality Engineer II

Fort Worth, TX · On-site

$69K - $89K/yr

Join a world-class medical device manufacturing site in Fort Worth, Texas with Medtronic! As a Quality Engineer at Medtronic Fort Worth, you will work at the forefront of spine surgery medical device ...

Medtronic

Quality Engineer II

Fort Worth, TX · On-site

$69K - $89K/yr

Join a world-class medical device manufacturing site in Fort Worth, Texas with Medtronic! As a Quality Engineer at Medtronic Fort Worth, you will work at the forefront of spine surgery medical device ...

CryoLife

Sr. Quality Engineer

Austin, TX · On-site

$87K - $118K/yr

This position utilizes Quality Engineering and Quality Assurance techniques and expertise to ... biomedical, medical device field) with an in-depth knowledge of current Good Manufacturing ...

Artivion

Sr. Quality Engineer

Austin, TX

$89K - $120K/yr

This position utilizes Quality Engineering and Quality Assurance techniques and expertise to ... biomedical, medical device field) with an in-depth knowledge of current Good Manufacturing ...

Abbott

Quality Engineer

Houston, TX · On-site

$68K - $88K/yr

Job Title Quality Engineer Working at Abbott At Abbott, you can do work that matters, grow, and ... Prior medical device experience preferred. Experience implementing various product and process ...

Abbott

Quality Engineer

Houston, TX · On-site

$68K - $88K/yr

Job Title Quality Engineer Working at Abbott At Abbott, you can do work that matters, grow, and ... Prior medical device experience preferred. Experience implementing various product and process ...

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All JobsQuality Engineer Medical Device JobsQuality Engineer Medical Device Jobs in Texas

Quality Engineer Medical Device information

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

As of Sep 3, 2026, the average hourly pay for quality engineer medical device in Texas is $34.21, according to ZipRecruiter salary data. Most workers in this role earn between $23.08 and $42.79 per hour, depending on experience, location, and employer.

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

A Quality Engineer in the medical device industry is responsible for ensuring that medical devices meet all regulatory standards and quality requirements. They develop and implement quality assurance processes, perform risk assessments, and conduct inspections and audits to make sure products are safe and effective. Quality Engineers also collaborate with design, manufacturing, and regulatory teams to resolve quality issues and improve product reliability. Their work is crucial for maintaining compliance with standards such as ISO 13485 and FDA regulations.

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

To thrive as a Quality Engineer in the medical device industry, you need a strong background in quality assurance, regulatory compliance (such as ISO 13485 and FDA 21 CFR Part 820), and engineering principles, often supported by a relevant engineering degree. Familiarity with quality management systems (QMS), risk analysis tools (like FMEA), and certifications such as CQE (Certified Quality Engineer) are typically required. Attention to detail, problem-solving, and effective communication are critical soft skills for collaborating with cross-functional teams and ensuring product safety. These skills and qualifications are vital to maintain regulatory compliance, uphold product quality, and protect patient safety in a highly regulated environment.

How does a quality engineer in the medical device industry typically collaborate with cross-functional teams to ensure product compliance?

Quality Engineers in the medical device sector work closely with cross-functional teams such as design, manufacturing, regulatory affairs, and supply chain. They participate in design reviews, risk assessments, and process validations to ensure that products meet both internal quality standards and external regulatory requirements (such as FDA or ISO 13485). Regular collaboration involves reviewing documentation, addressing non-conformances, and implementing corrective actions. This teamwork is critical to proactively identify potential issues and maintain continuous product quality throughout the development and production lifecycle.

What is the difference between Quality Engineer Medical Device vs Quality Assurance Specialist Medical Device?

AspectQuality Engineer Medical DeviceQuality Assurance Specialist Medical Device
CertificationsISO 13485, Six Sigma, ASQ certificationsISO 13485, Six Sigma, ASQ certifications
Work EnvironmentDesign, development, manufacturing, and process improvementAuditing, compliance, documentation, and process verification
Employer & Industry UsageMedical device manufacturers, R&D labsMedical device companies, regulatory agencies, consulting firms

While both roles focus on quality in the medical device industry, a Quality Engineer Medical Device primarily works on product design, process development, and continuous improvement. In contrast, a Quality Assurance Specialist Medical Device emphasizes compliance, auditing, and ensuring adherence to regulatory standards. Both roles are essential for maintaining product safety and quality, but they differ in scope and daily responsibilities.

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For Quality Engineer Medical Device jobs in Texas, the most frequently searched job titles are:

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Cities in Texas with the most Quality Engineer Medical Device job openings:

Quality Engineer Medical Device jobs near you
Infographic showing various Quality Engineer Medical Device job openings in Texas as of August 2026, with employment types broken down into 1% As Needed, 78% Full Time, 15% Part Time, and 6% Contract. Highlights an 92% Physical, 1% Hybrid, and 7% Remote job distribution, with an average salary of $71,164 per year, or $34.2 per hour.

Quality Engineer, Software Design Controls

Neuralink

Austin, TX • On-site

Full-time

Medical, Dental, Vision, Retirement

Posted 13 days ago

Job description

About Neuralink:
We are creating devices that enable a bi-directional interface with the brain. These devices allow us to restore movement to the paralyzed, restore sight to the blind, and revolutionize how humans interact with their digital world.
Team Description:
Join the Translational Team, where we generate the data that advances Neuralink's brain-computer interface technologies from research and development through clinical evaluation and into market implementation. We produce the rigorous evidence required to support rapid development, regulatory progress, and the safe, effective delivery of the technology to patients.
Job Description and Responsibilities:
The Quality Engineer, Software Design Controls will own software design control strategy, processes, documentation, and continuous improvement across implantable electronics software, surgical robotics software, external systems, and related non-product software. Responsibilities include:
  • Work directly with software and firmware teams to identify design control and software lifecycle risks early, drive robust mitigations, and support design reviews to embed strong design control and IEC 62304 practices.
  • Own software design control impact assessments for design changes within the medical device design control process; evaluate effects on requirements, architecture, risk controls, verification/validation, and traceability; determine re-test, analysis, or documentation needs; and update risk assessments, protocols, and Design History File (DHF) content to maintain ongoing compliance.
  • Own end-to-end software design control strategy and plan/execute activities supporting the full software lifecycle (requirements, architecture, detailed design, implementation, verification, validation, risk management, and release) for Class III and other regulated software in accordance with IEC 62304, ISO 14971, ISO 13485, and related standards.
  • Debug software quality and design control gaps using requirements management tools, traceability matrices, code/architecture reviews, test results, anomaly data, and root-cause analysis techniques; recommend effective process and design mitigations.
  • Develop, execute, and maintain software design control deliverables including design and development plans, software requirements specifications, architecture documents, verification/validation plans and reports, risk management files, traceability matrices, change control records, and requirement-to-test linkages for complex systems involving implants, chargers, robots, and supporting software.
  • Stay current with advancements in medical device software standards, regulatory science, and related technologies; contribute to continuous improvement of compliance processes, SOPs, templates, and knowledge sharing across teams.

Required Qualifications:
  • Bachelor's degree in Computer Science, Software Engineering, Biomedical Engineering, or related technical discipline.
  • 3+ years of hands-on experience with software design controls, software quality, or software design assurance for medical devices.
  • Strong understanding of the software development lifecycle (SDLC) in regulated or safety-critical environments and practical application of design controls.
  • Direct experience planning, executing, reviewing, and documenting software design control and verification/validation activities.
  • Working knowledge of IEC 62304 (Medical Device Software Lifecycle Processes), ISO 14971 (Risk Management), and ISO 13485.
  • Strong cross-functional communication skills and ability to drive issues to closure across engineering, quality, regulatory, and external partners.

Preferred Qualifications:
  • Experience with implants, surgical robotics, wireless systems, or Software as a Medical Device (SaMD) / Software in a Medical Device (SiMD).
  • Prior experience contributing software design control or V&V data to regulatory submissions (IDE, 510(k), PMA, or equivalent) and interfacing with FDA or notified bodies.
  • Experience with medical device design controls, ISO 14971 risk management (including software FMEA / SFMEA), cybersecurity risk assessment, and product development lifecycle in a regulated environment.
  • Experience developing software design control guidelines, training programs, templates, or compliance workflows that accelerate product development.
  • Familiarity with additional standards such as IEC 62366 (usability), 21 CFR Part 11, or cybersecurity guidance (FDA, IEC 81001-5-1).
  • Experience writing test protocols, reports, deviations, engineering rationales, risk assessments, and requirement traceability in a regulated or quality-controlled development process.

Expected Compensation:
The anticipated base salary for this position is expected to be within the following range. Your actual base pay will be determined by your job-related skills, experience, and relevant education or training. We also believe in aligning our employees' success with the company's long-term growth. As such, in addition to base salary, Neuralink offers equity compensation (in the form of Restricted Stock Units (RSU)) for all full-time employees.
Base Salary Range:
$103,000-$191,000 USD
What We Offer:
Full-time employees are eligible for the following benefits listed below.
  • An opportunity to change the world and work with some of the smartest and most talented experts from different fields
  • Growth potential; we rapidly advance team members who have an outsized impact
  • Excellent medical, dental, and vision insurance through a PPO plan
  • Paid holidays
  • Commuter benefits
  • Meals provided
  • Equity (RSUs) *Temporary Employees & Interns excluded
  • 401(k) plan *Interns initially excluded until they work 1,000 hours
  • Parental leave *Temporary Employees & Interns excluded
  • Flexible time off *Temporary Employees & Interns excluded

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