Medical Device Quality Technician Job Description [Updated for 2025]

In the era of advanced healthcare technology, the role of a Medical Device Quality Technician has become paramount.

As medical innovations continue to evolve, there is a growing need for meticulous individuals who can oversee, enhance, and ensure the quality of our medical devices.

But let’s delve deeper: What’s truly expected from a Medical Device Quality Technician?

Whether you are:

• A job seeker looking to grasp the depth of this role,
• A hiring manager outlining the perfect candidate,
• Or simply fascinated by the complexities of medical device quality control,

You’ve come to the right place.

Today, we present a customizable Medical Device Quality Technician job description template, devised for effortless posting on job boards or career sites.

Let’s dive right into it.

Medical Device Quality Technician Duties and Responsibilities

Medical Device Quality Technicians are responsible for ensuring that all medical devices are safe, effective, and of high quality.

They do this through a variety of tasks such as inspecting and testing devices, documenting and analyzing data, and ensuring compliance with regulatory standards.

Their main duties and responsibilities include:

• Inspecting and testing medical devices to ensure they meet specified requirements
• Recording and analyzing test data to validate or indicate deviations from existing standards
• Recommending necessary corrective actions based on test results
• Ensuring that quality control procedures are implemented and followed
• Maintaining and controlling calibration records for all test and inspection equipment
• Participating in the review of engineering designs to contribute quality requirements and considerations
• Assisting in the development and implementation of quality control training programs
• Reviewing and updating standard operating procedures or quality assurance manuals
• Ensuring compliance with regulatory standards such as the FDA and ISO

 

Medical Device Quality Technician Job Description Template

Job Brief

We are seeking a detail-oriented Medical Device Quality Technician to ensure our medical devices meet both internal and regulatory standards for safety and efficacy.

The primary responsibilities include conducting routine inspections, performing quality control tests, maintaining accurate documentation, and ensuring compliance with FDA and ISO regulations.

The ideal candidate will have a technical background, excellent attention to detail, and an unwavering commitment to ensuring the production of high-quality medical devices.

 

Responsibilities

• Perform quality control tests on medical devices to ensure they meet required standards
• Conduct routine inspections of the manufacturing process
• Maintain accurate and detailed documentation of quality control tests and inspections
• Identify and report any quality issues or deviations from standards
• Assist in the development and implementation of quality improvement strategies
• Ensure compliance with FDA, ISO and any other relevant standards
• Work closely with production teams to ensure quality control procedures are understood and followed
• Assist in the training of staff on quality control measures

 

Qualifications

• Proven experience as a Quality Technician, preferably in the medical device industry
• Technical background with an understanding of medical device technology
• Excellent attention to detail and precision
• Strong understanding of FDA, ISO and other relevant standards
• Excellent problem-solving skills
• Ability to create and maintain accurate and detailed reports
• Associate or Bachelor’s degree in Engineering, Quality Assurance or a related field is preferred

 

Benefits

• 401(k)
• Health insurance
• Dental insurance
• Retirement plan
• Paid time off
• Professional development opportunities

 

Additional Information

• Job Title: Medical Device Quality Technician
• Work Environment: Laboratory setting with strict adherence to safety protocols. Some travel may be required for industry conferences or trainings.
• Reporting Structure: Reports to the Quality Assurance Manager or Director.
• Salary: Salary is based upon candidate experience and qualifications, as well as market and business considerations.
• Pay Range: $49,783 minimum to $75,041 maximum
• Location: [City, State] (specify the location or indicate if remote)
• Employment Type: Full-time
• Equal Opportunity Statement: We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
• Application Instructions: Please submit your resume and a cover letter outlining your qualifications and experience to [email address or application portal].

 

What Does a Medical Device Quality Technician Do?

Medical Device Quality Technicians play a crucial role in the healthcare industry, particularly in companies that design and manufacture medical devices.

Their primary responsibility is to ensure that medical devices meet all necessary safety and quality standards.

They do this by conducting routine testing and inspections throughout various stages of the product development process.

These technicians maintain documentation related to the quality testing processes, such as test results, observations, and recommendations for improvements.

This data is used to track the effectiveness of quality control systems and to identify areas for improvement.

Medical Device Quality Technicians also analyze failure and defect reports, identifying patterns and trends that may indicate underlying design or manufacturing issues.

Based on their findings, they may recommend corrective actions or changes to prevent similar defects from occurring in the future.

They work closely with other departments, including design and production teams, to ensure that quality is considered at every stage of the medical device lifecycle, from initial concept through to manufacturing and after-sales service.

Moreover, these professionals are responsible for ensuring that the company adheres to industry regulations and standards, as well as any relevant legal requirements.

They may also be involved in training staff on quality control procedures to ensure consistent practices across the organization.

 

Medical Device Quality Technician Qualifications and Skills

Medical Device Quality Technicians should have a unique blend of technical skills, soft skills and industry knowledge that are necessary for ensuring the safety, reliability, and effectiveness of medical devices, including:

• Technical knowledge and understanding of medical device industry standards and regulations, such as ISO 13485 and FDA 21 CFR Part 820, to ensure compliance in all quality assurance processes.
• Proficiency in using measurement and inspection equipment, as well as software programs used for quality control and data analysis.
• Strong analytical and problem-solving skills to identify and correct potential quality issues, conduct root cause analysis, and implement corrective actions.
• Attention to detail and organizational skills for maintaining accurate documentation, conducting precise measurements, and tracking quality tests and investigations.
• Good interpersonal and communication skills for working with cross-functional teams, explaining quality control procedures, and reporting on quality metrics.
• Ability to interpret technical drawings and specifications, as well as to understand and apply complex technical standards.
• Experience in conducting internal and external audits, as well as working with regulatory bodies during inspections.

 

Medical Device Quality Technician Experience Requirements

Entry-level Medical Device Quality Technicians typically have 1 to 2 years of experience, which may be acquired through internships, co-op programs, or part-time positions.

This experience is often gained in a laboratory, cleanroom, or manufacturing setting, where they learn to inspect, test, and analyze medical equipment for quality control.

Candidates with 2 to 3 years of experience often hold certification from the American Society for Quality (ASQ) as a Certified Quality Technician or a similar qualification.

They have often developed their technical skills and understanding of quality systems in previous quality control or quality assurance roles within the medical device or similar industries.

Those with more than 5 years of experience typically have a more substantial background in quality management systems, regulatory compliance, and complex problem solving.

They might have been involved in the design and implementation of quality processes and procedures, trained other staff, or led quality improvement initiatives.

Candidates with more than 8 years of experience usually have significant leadership experience and may be ready for a managerial or supervisory position.

They may also have experience interfacing with regulatory agencies, managing audits, and overseeing entire quality management systems.

Advanced roles may also require a bachelor’s degree in engineering, life science, or a related field.

 

Medical Device Quality Technician Education and Training Requirements

A Medical Device Quality Technician typically requires an associate’s or bachelor’s degree in a science or engineering field, such as biomedical engineering or quality control.

In addition to the academic qualifications, an understanding of medical device manufacturing processes, quality control principles, and regulatory requirements is essential.

It is also beneficial to have knowledge about statistical methods for quality control, such as Six Sigma or Statistical Process Control.

Some roles may require certification from a recognized body such as the American Society for Quality (ASQ).

Certifications like Certified Quality Technician (CQT) or Certified Quality Engineer (CQE) can provide a competitive advantage.

Employers often prefer candidates with prior experience in quality assurance or a similar role in the medical device industry.

Therefore, internships or apprenticeships in the field can be beneficial.

Continued education and staying updated with the latest advancements in the field is important for career growth.

This can be achieved through industry-specific training programs or workshops.

Strong attention to detail, problem-solving skills, and proficiency in using quality control software are also important attributes for this role.

 

Medical Device Quality Technician Salary Expectations

A Medical Device Quality Technician earns an average salary of $58,856 (USD) per year.

The actual income may differ based on factors such as years of experience, level of education, certification, location, and the size and type of the employer.

 

Medical Device Quality Technician Job Description FAQs

What skills does a Medical Device Quality Technician need?

Medical Device Quality Technicians need a detailed understanding of quality control procedures and protocols.

They should be highly analytical, have good problem-solving skills, and be able to use statistical analysis software.

Understanding of the medical device industry and related regulations is also required.

Communication skills are important, as they need to effectively convey findings and recommendations to other team members and management.

 

Do Medical Device Quality Technicians need a degree?

While some employers may hire candidates with an associate’s degree or relevant certification, many prefer a bachelor’s degree in a scientific field such as Engineering, Biology, or Chemistry.

Some employers may require prior experience in quality assurance or in the medical device industry.

Industry-specific certifications such as Certified Quality Technician (CQT) or Certified Quality Auditor (CQA) may also be preferred.

 

What should you look for in a Medical Device Quality Technician resume?

Check for a degree in a relevant field and any certifications related to quality assurance.

Look for experience with quality control testing, inspections, and audits, particularly in the medical device industry.

Experience with statistical analysis software and knowledge of industry regulations and standards are also important.

Strong written and verbal communication skills should also be evident.

 

What qualities make a good Medical Device Quality Technician?

A good Medical Device Quality Technician is meticulous and pays high attention to detail, as they need to identify even the smallest deviations in product quality.

They should have strong problem-solving abilities to troubleshoot issues and come up with effective solutions.

They should be able to work both independently and as part of a team.

A continuous learner, they should stay updated on industry trends, regulations, and best practices.

 

What are the daily duties of a Medical Device Quality Technician?

On a typical day, a Medical Device Quality Technician might conduct inspections and tests on medical devices, document results, and compare them to established standards.

They could be involved in troubleshooting issues, implementing corrective actions, and verifying the effectiveness of these actions.

They may also collaborate with other departments to improve quality control procedures and participate in audits.

They need to keep up with regulatory changes and ensure that the organization’s practices comply with these standards.

 

Conclusion

So, there we have it.

Today, we’ve taken a closer look at the unsung heroes of the medical world – the Medical Device Quality Technicians.

Surprising, isn’t it?

It’s not just about running tests.

It’s about ensuring the safety and effectiveness of medical devices, one quality check at a time.

With our ready-to-use Medical Device Quality Technician job description template and realistic examples, you’re ready to take the next step.

But there’s more!

Delve deeper with our job description generator. It’s your go-to tool for crafting precision-based job listings or fine-tuning your resume to perfection.

Remember:

Every quality check is a part of the bigger picture.

Let’s ensure a healthier future. Together.

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