Cardiac Monitoring QA Engineer – Houston, TX

Are you a detail-oriented and highly skilled professional with a passion for ensuring the highest quality in medical technology? We are looking for a Cardiac Monitoring QA Engineer to join our team in Houston, TX. This is an exciting opportunity to play a crucial role in ensuring the reliability and precision of cardiac monitoring systems that help save lives. If you have experience in quality assurance within the healthcare technology sector and a strong background in testing and validation, we want to hear from you.

Make a Difference in Cardiac Monitoring Technology

As a Cardiac Monitoring QA Engineer, you will be responsible for ensuring the highest standards of quality in cardiac monitoring devices. Your expertise will help enhance patient care by ensuring that every product we deliver is safe, effective, and reliable. This role requires a deep understanding of medical device regulations, testing procedures, and quality standards, combined with a commitment to continuous improvement and innovation.

Key Responsibilities of the Cardiac Monitoring QA Engineer – Houston, TX

Quality Assurance & Testing: Lead the testing and validation of cardiac monitoring devices to ensure they meet the highest industry standards. Develop and execute detailed test plans and protocols for product verification and performance evaluations.

Regulatory Compliance & Documentation: Ensure all cardiac monitoring products comply with FDA regulations, ISO 13485, and other relevant industry standards. Maintain accurate and thorough documentation of testing procedures, results, and product changes to meet regulatory requirements.

Risk Assessment & Management: Conduct risk assessments to identify potential issues in product development and design. Work with cross-functional teams to implement solutions and ensure the devices are safe, effective, and compliant with quality standards.

Continuous Improvement & Process Optimization: Collaborate with engineering and product teams to identify areas for process improvement. Use data-driven approaches to enhance testing procedures, streamline workflows, and increase efficiency while maintaining quality.

Cross-functional Collaboration: Work closely with product development, engineering, and regulatory teams to ensure product quality throughout the development lifecycle. Provide valuable insights and feedback to improve the functionality and reliability of cardiac monitoring systems.

Troubleshooting & Issue Resolution: Identify, analyze, and resolve product defects and issues during the testing phase. Work with technical teams to provide solutions and ensure timely resolution of any quality-related problems.

Testing Automation & Tools Development: Contribute to the development and implementation of automated testing tools and frameworks. Continuously seek opportunities to integrate new technologies to improve testing efficiency and effectiveness.

Customer Safety & Satisfaction: Prioritize the safety of patients and healthcare professionals by ensuring the accuracy and reliability of all products. Ensure customer feedback is integrated into quality assurance processes to enhance product performance and user experience.

Reporting & Documentation: Prepare detailed reports summarizing test results, product performance, and quality assessments. Present findings to senior management and other stakeholders to support decision-making and product improvements.

Training & Mentorship: Provide training and mentorship to junior quality assurance engineers and other team members. Share knowledge and best practices to ensure consistent application of quality standards across the team.

What the Client is Looking for in You – Cardiac Monitoring QA Engineer

As a Cardiac Monitoring QA Engineer, the client seeks a highly skilled and detail-oriented professional with a strong background in quality assurance for medical devices. You should have a deep understanding of cardiac monitoring technologies and the regulatory frameworks governing their development and use. The client values candidates who are passionate about ensuring the highest level of quality in healthcare technology while working in a fast-paced and dynamic environment.

Proven Expertise in Medical Device QA

The client is looking for a QA engineer with experience in testing and validating medical devices, specifically in the cardiac monitoring sector. You should have a proven track record of ensuring compliance with FDA regulations, ISO 13485, and other relevant standards. Familiarity with risk management, design controls, and test automation tools will be highly valued. Experience in the healthcare technology industry is essential for success in this role.

Strong Analytical and Problem-Solving Skills

As a QA engineer, you must demonstrate strong analytical abilities and a keen eye for detail. The ideal candidate will be adept at identifying potential issues early in the development process and implementing solutions to ensure product reliability and safety. The client seeks a professional who can think critically, troubleshoot complex issues, and take proactive measures to address any risks.

Commitment to Regulatory Compliance

The client is looking for a candidate who understands the importance of regulatory compliance and can navigate the complexities of medical device certifications and standards. You should be comfortable working in a regulated environment and possess the knowledge to ensure that all cardiac monitoring devices meet or exceed the necessary quality, safety, and efficacy requirements.

Collaborative Team Player

The ability to work collaboratively with cross-functional teams, including engineering, product development, and regulatory affairs, is key to this role. The client values a QA engineer who can provide valuable insights, contribute to product improvements, and ensure that the entire team is aligned with quality assurance objectives. A strong communicator who can work effectively in a team-oriented environment is essential.

Attention to Detail and Continuous Improvement Mindset

The client seeks a QA engineer with a high level of attention to detail and a commitment to continuous improvement. You should be passionate about identifying areas for enhancement, optimizing testing processes, and implementing best practices to increase efficiency and product quality. The ideal candidate will be proactive in adopting new technologies and methodologies to improve testing capabilities.

Customer and Patient-Centered Approach

A focus on patient safety and product reliability is essential in this role. The client is looking for a QA engineer who always puts the consumer’s well-being at the forefront and ensures that every cardiac monitoring product meets the highest standards for accuracy, safety, and performance.

Strong Documentation and Reporting Skills

The client values candidates who can produce clear, accurate, and detailed documentation for test procedures, results, and any identified issues. The ability to present data in a structured and understandable way will be crucial for reporting to stakeholders and ensuring transparency throughout the product development process.

FAQs About the Role – Cardiac Monitoring QA Engineer – Houston, TX

What are the key responsibilities of the Cardiac Monitoring QA Engineer in this role?

As a Cardiac Monitoring QA Engineer, your primary responsibilities include testing and validating cardiac monitoring devices to ensure they meet quality and regulatory standards. You will work on developing test plans, executing tests, and ensuring products comply with FDA regulations and ISO 13485. Additionally, you will conduct risk assessments, troubleshoot defects, optimize testing processes, and collaborate with engineering teams to improve product performance.

What qualifications and experience are required for this position?

The ideal candidate should have a strong background in quality assurance for medical devices, particularly in the cardiac monitoring sector. Experience in regulatory compliance (FDA, ISO 13485) and risk management is essential. A degree in Biomedical Engineering, Electrical Engineering, or a related field is preferred. Additionally, proficiency in test automation tools, validation processes, and medical device development will be highly valued.

What technical skills are required for this role?

You should have experience with automated testing tools, data analysis, and test management software. Knowledge of cardiac monitoring systems, device validation, and risk management is crucial. Familiarity with regulatory standards such as FDA guidelines and ISO 13485, as well as experience with documentation and reporting for compliance, is essential. Proficiency in programming languages for automation (e.g., Python, Java) is a plus.

What challenges can I expect in this role?

You may encounter challenges such as ensuring compliance with complex regulatory requirements, managing product defects, and ensuring the safety and reliability of cardiac devices. As technology evolves, you will need to stay updated on new testing methodologies and adapt to changing industry standards. Balancing the fast-paced nature of development while ensuring thorough testing and validation will also be a challenge.

What is the expected impact of the QA Engineer on the company’s products?

The QA Engineer plays a crucial role in ensuring the safety, efficacy, and reliability of cardiac monitoring devices. Your work directly impacts product quality, customer safety, and regulatory compliance. By identifying and addressing quality issues early, you help reduce risks, enhance the customer experience, and contribute to the company’s reputation as a leader in medical technology.

What is the company’s culture and work environment like?

The company fosters a collaborative and innovative work environment, focusing on delivering high-quality, life-saving products. You will be part of a team that prioritizes patient safety, regulatory compliance, and continuous improvement. The work environment is dynamic and fast-paced, offering opportunities for growth and advancement in the medical device field.

What Remuneration Can You Expect from This Job?

As the Cardiac Monitoring QA Engineer in Houston, TX, you can expect a competitive and comprehensive compensation package. The remuneration for this role typically includes:

Base Salary

The base salary for a Cardiac Monitoring QA Engineer varies depending on the company, experience, and skill set. On average, the annual base salary for this role ranges from $70,000 to $110,000, with higher salaries possible for candidates with extensive experience or specialized expertise in cardiac monitoring and medical device quality assurance.

Performance-Based Bonuses

In addition to the base salary, many companies offer performance-based bonuses. These bonuses are typically linked to key performance indicators such as successful product testing, compliance with regulatory standards, and contributions to product quality improvement. Bonuses can range from 10% to 20% of the base salary, depending on company and individual performance.

Equity & Stock Options

Some companies may offer stock options or other equity-based incentives as part of the compensation package. This allows employees to share in the company’s success and align their interests with the company’s long-term goals. Equity compensation can vary widely but may offer significant value in the long term, especially if the company is growing or preparing for an IPO.

Health & Wellness Benefits

As a Cardiac Monitoring QA Engineer, you will likely receive comprehensive health benefits, including:

Health, dental, and vision insurance
Employee wellness programs
Access to mental health support and counseling services

Retirement Plans & Financial Security

Companies often provide retirement savings options, including 401(k) plans with employer contributions. Some employers may also offer pension plans or other long-term savings plans designed to help you plan for the future.

Additional Perks & Benefits

As part of the compensation package, you may also receive additional perks such as:

Paid time off (PTO) and holiday leave
Professional development opportunities and educational assistance
Relocation assistance (if applicable)
Company-sponsored events and social activities

Total Compensation Potential

Considering the base salary, performance bonuses, benefits, and potential equity or stock options, the total compensation for a Cardiac Monitoring QA Engineer can range from $80,000 to $130,000 annually, with higher potential earnings for those with advanced expertise or significant contributions to the company’s success.

How to Apply

If you are an experienced Cardiac Monitoring QA Engineer with a strong background in medical device quality assurance, we invite you to apply for the role in Houston, TX. This is an exciting opportunity to contribute to the success of cutting-edge cardiac monitoring products, ensuring their safety, reliability, and compliance with regulatory standards.

To apply, please submit the following:

Resume: Include your relevant work experience, highlighting your expertise in quality assurance, testing methodologies, and familiarity with cardiac monitoring devices.
Cover Letter: In your cover letter, detail your experience with medical device testing, your familiarity with regulatory guidelines (such as FDA and ISO), and any projects where you’ve contributed to improving product quality. Highlight how your skills will add value to the role and the company.
Certifications (if applicable): If you hold any relevant certifications, such as Certified Quality Engineer (CQE), Six Sigma, or other relevant qualifications, please include them in your application.

This role offers an excellent opportunity to be part of a rapidly growing organization focused on improving cardiac care through innovative technology. If you have the skills and drive to make a significant impact in the medical device industry, apply today!

For more information or to explore similar opportunities, visit our Healthcare & Medical Device Careers Page.

Job Category: Medical Device

Job Type: Full Time

Job Location: Houston

Cardiac Monitoring QA Engineer – Houston, TX