At-Home Diagnostic Device QA Inspector – Cleveland, OH

Are you detail-oriented and passionate about quality assurance in healthcare technology? We are seeking a QA Inspector to join a fast-growing medical diagnostics company focused on at-home testing solutions. Based in Cleveland, OH, this role offers the opportunity to ensure the highest standards of product safety, accuracy, and compliance in a rapidly evolving health tech landscape. If you have a sharp eye for detail and a strong commitment to quality, this position is ideal for you.

Ensure Product Excellence in At-Home Healthcare Innovation

A leading diagnostics company in Cleveland, OH is hiring a Quality Assurance (QA) Inspector to support its line of at-home diagnostic devices. The successful candidate will play a critical role in maintaining regulatory compliance, identifying defects, and ensuring every product meets stringent industry standards. If you’re experienced in medical device QA and looking to contribute to groundbreaking healthcare solutions that empower consumers, we invite you to apply.

Key Responsibilities of the At-Home Diagnostic Device QA Inspector – Cleveland, OH

Quality Assurance & Inspection: Perform detailed inspections of at-home diagnostic devices to ensure compliance with internal specifications, regulatory standards, and quality guidelines. Identify and document defects, inconsistencies, or deviations from product requirements.

Regulatory Compliance Monitoring: Ensure all products meet FDA, ISO, and other applicable regulatory standards. Assist in audits and maintain accurate documentation for regulatory submissions and inspections.

Testing & Validation: Conduct product testing using standardized procedures and maintain meticulous records of test results. Collaborate with engineering and R&D teams to validate product functionality and reliability.

Process Improvement: Recommend and support improvements to inspection procedures, manufacturing processes, and quality control protocols. Assist in root cause analysis and implementation of corrective and preventive actions (CAPA).

Documentation & Reporting: Accurately complete quality control reports, inspection checklists, and non-conformance logs. Maintain detailed records of product evaluations and assist in preparing QA metrics and reports for management.

Cross-Functional Collaboration: Work closely with production, engineering, and regulatory teams to ensure consistent quality across the product lifecycle. Support internal training and knowledge-sharing related to quality standards.

Inventory & Batch Verification: Verify product labels, batch numbers, and expiration dates for accuracy. Assist in product quarantine, rework, or disposal processes as needed to maintain product integrity.

Health & Safety Compliance: Adhere to company health and safety standards while performing inspections. Ensure that the testing environment remains clean, organized, and free of hazards.

Continuous Learning & Development: Stay current on industry trends, new QA technologies, and evolving regulatory requirements to support continuous improvement in quality systems and practices.

What the Client is Looking for in You

As an At-Home Diagnostic Device QA Inspector, the client is seeking a highly meticulous and detail-oriented professional who is passionate about product quality and patient safety. You should have a strong background in medical device quality assurance and a proactive approach to identifying and resolving issues. This role requires a combination of technical expertise, regulatory knowledge, and a commitment to excellence in healthcare innovation.

Hands-On Experience in Medical Device QA

The ideal candidate will have prior experience inspecting and testing medical or diagnostic devices in a regulated environment. You should be well-versed in quality control practices, documentation standards, and industry-specific inspection techniques. Experience working with at-home or point-of-care devices is highly valued.

Strong Knowledge of Regulatory Standards

The client is looking for someone who understands and adheres to FDA, ISO 13485, and other relevant regulatory standards. Your ability to ensure full compliance with these regulations and contribute to audit preparedness is essential. Familiarity with Good Manufacturing Practices (GMP) and CAPA processes is highly preferred.

Attention to Detail and Analytical Skills

Success in this role depends on your ability to identify even the smallest inconsistencies or deviations. You must demonstrate strong observational and analytical skills, ensuring that all products meet rigorous quality benchmarks before reaching consumers.

Proactive and Process-Oriented

The client values individuals who take initiative to improve inspection protocols and quality processes. You should be someone who doesn’t just spot issues, but also proposes practical solutions to enhance efficiency and accuracy.

Collaborative Team Player

While much of the work is focused on product inspection, collaboration with production, engineering, and regulatory teams is crucial. The client is looking for a QA Inspector who communicates effectively and contributes to a strong culture of quality throughout the organization.

Commitment to Health & Safety

Given the healthcare focus of the company, a strong commitment to workplace safety and hygiene standards is non-negotiable. The ideal candidate prioritizes safety in all inspection and testing activities to protect both users and team members.

Continuous Learner with a Growth Mindset

Finally, the client appreciates individuals who stay updated on industry trends, new inspection technologies, and evolving quality standards. Your willingness to learn and adapt will be key to thriving in a dynamic, innovation-driven environment.

FAQs About the Role – At-Home Diagnostic Device QA Inspector – Cleveland, OH

1. What are the key responsibilities of the QA Inspector in this role?

As the At-Home Diagnostic Device QA Inspector, you will be responsible for performing detailed inspections and tests on diagnostic devices to ensure they meet regulatory standards and product specifications. You will document and report any defects, assist in audits, and support corrective actions. You’ll also collaborate with engineering, production, and regulatory teams to ensure product quality and safety throughout the production process.

2. What qualifications and experience are required for this position?

The ideal candidate should have a background in quality assurance, preferably within the medical device or healthcare industry. Experience with FDA regulations, ISO standards (such as ISO 13485), and Good Manufacturing Practices (GMP) is highly desirable. You should have strong attention to detail, experience with inspection tools, and a solid understanding of regulatory compliance. A degree in a related field (e.g., biomedical engineering, quality management, or life sciences) is preferred but not mandatory.

3. What technical skills are essential for this role?

You should have hands-on experience with various testing and inspection methods used in the medical device industry. Proficiency in using inspection tools, such as calipers, micrometers, and other measurement devices, is crucial. Additionally, experience with quality management systems (QMS) software, defect tracking tools, and documentation systems is highly beneficial. Familiarity with statistical process control (SPC) and other data analysis techniques will also be an asset.

4. What challenges can I expect in this role?

As a QA Inspector, you may face challenges related to ensuring consistent product quality across large volumes of production. You will need to stay updated on evolving regulatory standards and maintain high inspection accuracy under tight deadlines. Managing multiple tasks, handling complex defect identification, and working in collaboration with other departments to resolve issues will require problem-solving skills and flexibility.

5. What is the expected impact of the QA Inspector on the company’s products?

Your work as a QA Inspector is critical in ensuring the reliability, safety, and effectiveness of the at-home diagnostic devices. You will directly impact product quality by identifying issues early in the production process, helping reduce recalls and improving customer satisfaction. Your attention to detail and thorough documentation will contribute to maintaining regulatory compliance and enhancing the company’s reputation for quality.

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

The company fosters a collaborative, quality-driven, and innovation-oriented environment. You will work with cross-functional teams, including engineering, production, and regulatory compliance, to maintain high-quality standards. The company values a culture of continuous improvement and encourages employees to contribute ideas and feedback to improve processes and products. Safety, accuracy, and compliance are top priorities, and the team is committed to delivering safe, high-quality products to consumers.

What Remuneration Can You Expect from This Job?

As the At-Home Diagnostic Device QA Inspector in Cleveland, OH, you can expect a competitive and attractive compensation package that reflects the skills and responsibilities required for the role. The remuneration for this position typically includes:

1. Base Salary

The base salary for a QA Inspector in the healthcare and medical device industry generally ranges from $45,000 to $75,000 per year. The salary may vary based on your level of experience, education, and the specific needs of the company. Companies with a focus on quality and regulatory compliance may offer competitive compensation based on industry standards.

2. Performance-Based Bonuses

In addition to the base salary, many companies offer annual performance-based bonuses. These bonuses are typically tied to personal and team performance metrics such as product quality, defect reduction, and timely project completion. Bonuses can range from 5% to 15% of the base salary, depending on the organization’s performance and individual contribution.

3. Health & Wellness Benefits

QA Inspectors are often provided with comprehensive health benefits, including:

Health, dental, and vision insurance
Mental health support programs
Employee wellness initiatives
Access to fitness programs or gym memberships

4. Retirement Plans

Most companies offer retirement plans such as 401(k) or pension plans with company contributions. This helps ensure long-term financial security for employees.

5. Paid Time Off (PTO) & Holidays

As part of the compensation package, QA Inspectors typically receive paid time off, including vacation days, sick leave, and holidays. The amount of PTO may vary depending on company policy and the length of employment.

6. Signing Bonuses & Relocation Assistance

For highly sought-after candidates or those relocating to Cleveland, OH, some companies may offer signing bonuses or relocation assistance. These one-time incentives can help cover moving costs and ensure a smooth transition.

Total Compensation Potential

When considering base salary, bonuses, benefits, and additional perks, the total annual compensation for a QA Inspector can range from $50,000 to $85,000. Experienced professionals in high-demand markets or specialized sectors may receive compensation on the higher end of this spectrum.

How to Apply

If you are an experienced quality assurance professional with a strong background in the healthcare or medical device industry, we encourage you to apply for the At-Home Diagnostic Device QA Inspector position in Cleveland, OH. This is a fantastic opportunity to contribute to the development and quality assurance of innovative diagnostic devices that impact lives.

To apply, please submit your updated resume along with a cover letter that outlines your experience in quality assurance, regulatory compliance, and medical device inspection. Be sure to highlight your attention to detail, experience in conducting tests and inspections, and your understanding of industry standards such as FDA regulations, ISO certifications, and GMP practices.

This role offers a rewarding career opportunity where you will play a crucial role in ensuring the safety and quality of diagnostic devices used in home healthcare. Apply today to take the next step in your career as a QA Inspector in Cleveland, OH!

For more information or to explore similar opportunities, visit our Healthcare Quality Assurance Careers Page.

Job Category: Medical Device

Job Type: Full Time

Job Location: Cleveland

At-Home Diagnostic Device QA Inspector – Cleveland, OH