Medical Devices Quality Control Specialist Job Description [Updated for 2025]

In the ever-evolving field of healthcare, the focus on Medical Devices Quality Control Specialists is increasingly important.

As medical technology advances, the demand for skilled professionals who can ensure the quality, safety, and efficacy of medical devices grows exponentially.

But let’s delve deeper: What’s really expected from a Medical Devices Quality Control Specialist?

Whether you are:

• A job seeker trying to understand the intricacies of this role,
• A hiring manager crafting the perfect job description,
• Or simply curious about the world of medical device quality control,

You’re in the right place.

Today, we present a customizable Medical Devices Quality Control Specialist job description template, designed for effortless posting on job boards or career sites.

Let’s get started.

Medical Devices Quality Control Specialist Duties and Responsibilities

Medical Devices Quality Control Specialists are responsible for ensuring that medical devices meet the established standards of quality including reliability, usability and performance.

They are also responsible for the implementation and maintenance of quality control systems and procedures.

Their daily duties and responsibilities include:

• Inspect and test medical devices to ensure they meet the required quality standards and specifications
• Analyze the results of tests and inspections to identify and address any defects or deviations from standards
• Document inspection outcomes by completing detailed reports and performance records
• Develop, implement and maintain quality control systems and procedures
• Collaborate with production teams to improve and rectify quality issues
• Maintain up-to-date knowledge of regulatory standards and ensure compliance with these standards
• Coordinate with external quality assurance auditors and technicians to ensure legal compliance
• Recommend corrective actions when necessary and follow up to ensure that these actions have been effectively implemented
• Train and mentor junior quality control staff and other personnel on quality control activities

 

Medical Devices Quality Control Specialist Job Description Template

Job Brief

We are seeking a dedicated Medical Devices Quality Control Specialist to ensure our medical devices meet the highest industry standards.

Your responsibilities will include conducting regular inspections, performing tests, maintaining detailed reports, and ensuring compliance with regulatory guidelines.

Our ideal candidate will have a keen eye for detail, a sound understanding of medical device regulations, and a commitment to maintain the highest quality standards.

 

Responsibilities

• Perform routine inspections and quality tests on medical devices
• Compile and evaluate data to determine and maintain quality and reliability of products
• Manage documentation of inspections and test results
• Conduct root cause analysis for defects and non-conformance
• Collaborate with production and development teams to implement quality control processes
• Ensure products adhere to company and industry quality standards
• Update quality control standards in accordance with new regulations
• Monitor risk-management procedures, and maintain and analyze problem logs to identify and report recurring issues to management and product development

 

Qualifications

• Proven experience in quality control or similar role in the medical device industry
• Thorough knowledge of quality control standards and methodologies
• Familiarity with current medical device regulations and standards
• Ability to interpret and implement quality assurance standards
• Strong computer skills and experience with databases and quality control applications
• Attention to detail and problem-solving ability
• Strong written and verbal communication skills
• Bachelor’s degree in quality, industrial, or mechanical engineering

 

Benefits

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

 

Additional Information

• Job Title: Medical Devices Quality Control Specialist
• Work Environment: Office and laboratory setting. Some local travel may be required for industry seminars and training.
• Reporting Structure: Reports to the Quality Control Manager.
• Salary: Salary is based upon candidate experience and qualifications, as well as market and business considerations.
• Pay Range: $65,000 minimum to $95,000 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 Devices Quality Control Specialist Do?

A Medical Devices Quality Control Specialist primarily works in the healthcare or pharmaceutical industries, specifically within manufacturing or production departments of medical device companies.

They are responsible for testing medical devices to ensure they meet the strict standards of safety and effectiveness.

This typically involves conducting various physical, chemical, and microbiological tests on these devices and documenting the results.

Quality control specialists work in collaboration with other teams, like production, research and development, and regulatory affairs, to ensure the quality of the product from design to delivery.

They contribute to the development of quality control standards and ensure these are adhered to throughout the manufacturing process.

A key part of their job is to identify any defects or deviations from the set standards, report them and initiate corrective actions.

They must also maintain detailed records of all tests and inspections that are carried out.

In addition, they often participate in internal and external audits, where they must demonstrate compliance with all necessary regulations and standards.

They are also expected to stay updated with industry trends, regulatory changes, and advancements in technology to ensure the devices they are testing are up to date and meet all necessary requirements.

 

Medical Devices Quality Control Specialist Qualifications and Skills

A Medical Devices Quality Control Specialist ensures the safety and efficiency of medical devices before they reach the market.

The skills and qualifications needed for this role include:

• Strong attention to detail to identify even the smallest defects or inconsistencies in medical devices.
• Understanding of medical device regulations and standards to ensure devices comply with necessary guidelines and policies.
• Technical knowledge and understanding of medical devices to evaluate their functionality and effectiveness accurately.
• Problem-solving skills to identify potential issues and devise solutions to ensure quality control.
• Strong data analysis skills to interpret results of tests and inspections.
• Excellent communication skills to effectively relay information about quality control processes and device defects to manufacturers and other relevant parties.
• Time management skills to handle multiple tasks and meet deadlines for quality control procedures.
• Experience with quality control software and tools used for testing and inspecting medical devices.

 

Medical Devices Quality Control Specialist Experience Requirements

Entry-level candidates for the role of a Medical Devices Quality Control Specialist usually require a minimum of a Bachelor’s degree in biomedical engineering, medical technology, or a related field, with up to 2 years of experience in the medical device industry.

This could be gained through internships, cooperative education programs, or entry-level positions in the medical device or pharmaceutical industry.

Candidates with more than 3 years of experience often have a wider range of skills including strong analytical, problem-solving, and decision-making abilities, as well as detailed knowledge of medical device quality systems and industry regulations.

Such professionals may have worked in roles such as Quality Assurance Analyst, Medical Device Engineer, or Regulatory Affairs Specialist.

Those with more than 5 years of experience typically have advanced expertise in the medical device field, with a thorough understanding of regulatory compliance, quality control methodologies, and best practices.

They may have also acquired leadership and project management experience, making them suitable for senior or managerial roles in the quality control department.

Some roles may also require specific certifications such as Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or Certified Quality Improvement Associate (CQIA), which demonstrate a high level of competence and commitment to the field.

 

Medical Devices Quality Control Specialist Education and Training Requirements

Medical Devices Quality Control Specialists typically need a bachelor’s degree in a relevant field, such as biology, chemistry, bioengineering, or a related scientific field.

Their education typically involves coursework in medical technology, statistics, microbiology, chemistry, and biochemistry.

In addition to the bachelor’s degree, some positions may require a master’s degree or Ph.D. in quality assurance, regulatory affairs, or a closely related field.

Experience with analytical scientific testing and knowledge of FDA regulations and ISO (International Organization for Standardization) standards are crucial for this role.

This experience is often obtained through internships or entry-level positions in a quality control setting.

Certifications such as Certified Quality Auditor (CQA), Certified Quality Engineer (CQE), or Certified Quality Improvement Associate (CQIA) from American Society for Quality (ASQ) can be beneficial and may be preferred by some employers.

Additional training in Good Manufacturing Practice (GMP) and Quality Management Systems (QMS) is often required as these are key aspects of quality control in medical devices.

Continuous professional development and staying updated with the latest regulations, standards, and technological advances in the field is crucial for career advancement and effectiveness in the role.

 

Medical Devices Quality Control Specialist Salary Expectations

A Medical Devices Quality Control Specialist earns an average salary of $71,342 (USD) per year.

The actual compensation can differ based on factors such as experience, educational qualifications, location, and the size and type of employing organization.

 

Medical Devices Quality Control Specialist Job Description FAQs

What skills does a Medical Devices Quality Control Specialist need?

A Medical Devices Quality Control Specialist needs to have excellent attention to detail and organizational skills, as they will often be managing multiple projects at once.

They should possess strong analytical skills to understand complex quality control processes and principles.

Proficiency in using various inspection tools and equipment and knowledge in statistical methods for quality control is also important.

Additionally, they should have good communication skills to effectively collaborate with different teams in the organization.

 

Do Medical Devices Quality Control Specialists need a specific degree?

Most employers prefer Medical Devices Quality Control Specialists to have a bachelor’s degree in a related field such as Quality Assurance, Industrial Engineering, or Biomedical Engineering.

However, experience in the field of quality control, especially in the medical devices industry, can sometimes be considered in lieu of formal education.

Many roles also require a thorough understanding of relevant regulations and standards, such as FDA and ISO regulations.

 

What should you look for in a Medical Devices Quality Control Specialist resume?

A Medical Devices Quality Control Specialist resume should demonstrate an understanding of quality control principles and methodologies.

Look for specific experience with medical devices and familiarity with FDA and ISO regulations.

Any certification related to quality control, like a Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA), is a plus.

Evidence of problem-solving skills and strong attention to detail is also beneficial.

 

What qualities make a good Medical Devices Quality Control Specialist?

A good Medical Devices Quality Control Specialist is detail-oriented, analytical, and possesses excellent problem-solving skills.

They should be able to work independently and as part of a team, demonstrating strong communication skills.

They should have a firm understanding of regulatory standards, and the ability to stay updated on changes in these standards.

Proactive individuals who take the initiative to identify potential issues and implement corrective actions make excellent Quality Control Specialists.

 

Is it difficult to hire Medical Devices Quality Control Specialists?

Finding the right Medical Devices Quality Control Specialist can be a challenge due to the specific set of skills and knowledge required for this role.

The industry is highly specialized and regulated, making it important to find candidates with the necessary experience and understanding of the field.

Furthermore, it is crucial to find someone who is meticulous and can handle high levels of responsibility.

Offering competitive compensation and opportunities for professional development can help attract qualified candidates.

 

Conclusion

And there you have it.

Today, we’ve unveiled the intricacies of what it truly means to be a Medical Devices Quality Control Specialist.

Guess what?

It’s not just about technical inspection.

It’s about maintaining the highest standards in healthcare, one device at a time.

With our definitive Medical Devices Quality Control Specialist job description template and real-world examples, you’re ready to take the next step.

But why limit yourself?

Go further with our job description generator. It’s your key to creating detailed job listings or refining your resume to perfection.

Remember:

Every device inspected contributes to the bigger picture of health and wellness.

Let’s enhance healthcare quality. Together.

How to Become a Medical Devices Quality Control Specialist (Complete Guide)

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