Quality Assurance Specialist Laboratory Diagnostics – Dallas, TX
Are you a detail-oriented quality assurance professional passionate about ensuring the highest standards in laboratory diagnostics? We are seeking a Quality Assurance Specialist to join our Dallas-based diagnostics team. This role offers a unique opportunity to play a critical part in maintaining regulatory compliance, optimizing quality systems, and safeguarding product excellence in a fast-evolving healthcare environment.
Drive Quality and Compliance in Cutting-Edge Diagnostics
Our laboratory diagnostics company in Dallas is looking for a Quality Assurance Specialist to uphold rigorous quality standards and support continuous improvement initiatives. The ideal candidate will bring expertise in regulatory frameworks, quality management systems, and cross-functional collaboration to ensure laboratory processes meet both internal benchmarks and external regulatory requirements. If you are dedicated to precision, compliance, and advancing diagnostic solutions, this is your chance to make a meaningful impact.
Key Responsibilities of the Quality Assurance Specialist – Laboratory Diagnostics
Quality Management & Compliance:
Develop, implement, and maintain quality assurance procedures and systems in alignment with regulatory requirements such as CLIA, CAP, FDA, and ISO standards. Ensure all laboratory operations meet or exceed internal and external quality benchmarks to maintain accreditation and certification status.
Documentation & Reporting:
Manage and review documentation related to quality control, standard operating procedures (SOPs), deviations, and corrective actions. Prepare detailed quality reports and assist in audits and inspections by regulatory bodies.
Process Improvement & Risk Management:
Identify potential quality risks and non-conformities within laboratory processes. Lead root cause analyses and implement corrective and preventive actions (CAPA) to drive continuous improvement and minimize errors.
Cross-Functional Collaboration:
Work closely with laboratory scientists, production teams, and regulatory affairs to ensure seamless integration of quality assurance practices into daily operations. Support training initiatives to enhance quality awareness and compliance across departments.
Audit & Inspection Support:
Coordinate and participate in internal and external audits, ensuring timely resolution of audit findings. Maintain readiness for regulatory inspections and contribute to successful compliance outcomes.
Product Release & Validation:
Review and approve laboratory test results and validation protocols, ensuring products and diagnostic assays meet quality specifications before release.
Data Integrity & Accuracy:
Ensure accuracy, reliability, and traceability of laboratory data by monitoring quality control charts, calibrations, and equipment performance.
What the Client is Looking for in You
As the Quality Assurance Specialist – Laboratory Diagnostics, the client seeks a detail-driven professional with a deep understanding of quality systems and regulatory compliance in a laboratory or clinical diagnostics setting. You should be proactive, organized, and capable of driving continuous improvement in quality processes while supporting laboratory teams in delivering reliable and accurate diagnostic outcomes.
Experience in Laboratory Quality Systems and Compliance
The ideal candidate will have a solid background in laboratory diagnostics with hands-on experience in managing quality assurance programs under regulatory frameworks such as CLIA, CAP, FDA, or ISO 13485. Familiarity with Good Laboratory Practices (GLP) and experience preparing for audits and inspections are highly valued.
Strong Analytical and Documentation Skills
The client is looking for a QA specialist who is meticulous in documentation and skilled in conducting root cause analysis, implementing corrective and preventive actions (CAPA), and maintaining SOPs. Your ability to analyze trends, assess risks, and develop action plans will be essential to maintaining quality standards.
Process-Oriented with a Commitment to Excellence
You should bring a process-driven mindset with the ability to identify gaps, optimize workflows, and support the implementation of best practices across laboratory operations. The client values professionals who strive for excellence and consistency in all aspects of quality control and assurance.
Collaborative and Cross-Functional Communicator
Success in this role requires strong communication and interpersonal skills. You will be expected to work collaboratively with lab technicians, regulatory teams, and operational staff to ensure seamless execution of quality initiatives. The ability to educate and guide teams on compliance protocols is a key asset.
Knowledge of Diagnostic Technology and Laboratory Tools
The client prefers candidates who are familiar with modern diagnostic tools, testing methodologies, and lab instrumentation. A working knowledge of LIMS (Laboratory Information Management Systems) and data integrity best practices is a strong advantage.
Proactive in Continuous Improvement
The client values a candidate who embraces a culture of quality and continuous improvement. Your ability to initiate quality audits, propose enhancements, and support implementation of change initiatives will be instrumental to driving compliance and efficiency.
Ethical Standards and Regulatory Integrity
A strong commitment to ethical conduct, data accuracy, and adherence to healthcare regulations is non-negotiable. You should be vigilant in upholding the highest standards of patient safety, data security, and operational integrity in all QA processes.
FAQs About the Role – Quality Assurance Specialist – Laboratory Diagnostics – Dallas, TX
1. What are the key responsibilities of the Quality Assurance Specialist in this role?
As a Quality Assurance Specialist, you will be responsible for ensuring the accuracy and integrity of diagnostic processes, maintaining compliance with regulatory standards (such as CLIA, CAP, FDA, and ISO), and driving continuous improvement initiatives. You will oversee documentation, support audits, analyze quality trends, and collaborate with cross-functional teams to uphold high-quality laboratory operations.
2. What qualifications and experience are required for this position?
The ideal candidate should have a background in quality assurance within a clinical or laboratory diagnostics environment. Experience with quality management systems (QMS), regulatory compliance, audit preparation, and CAPA processes is essential. A degree in medical technology, life sciences, or a related field is typically required. Certifications such as ASQ-CQA or Six Sigma are a plus but not mandatory.
3. What skills and qualities are essential for success in this role?
Attention to detail, strong analytical and documentation skills, and a deep understanding of quality assurance principles are critical. The client values professionals who can work independently, communicate effectively across departments, and proactively identify areas for improvement. Familiarity with LIMS and electronic documentation systems is highly desirable.
4. What challenges can I expect in this role?
You may encounter challenges such as navigating complex regulatory requirements, managing time-sensitive quality issues, and implementing improvements in a high-throughput diagnostic setting. Balancing compliance with efficiency, supporting multiple audits, and fostering quality awareness among laboratory teams will be part of your daily responsibilities.
5. What impact does this role have on the organization?
The Quality Assurance Specialist plays a vital role in ensuring that diagnostic testing is accurate, reliable, and compliant with industry standards. Your work directly impacts patient safety, regulatory standing, and operational excellence. By supporting quality initiatives, you contribute to the organization’s reputation and success in the diagnostics market.
6. What is the team and work environment like?
The client promotes a collaborative, detail-focused, and science-driven work environment. You will be part of a supportive team of professionals dedicated to high standards in healthcare diagnostics. Continuous learning, quality improvement, and regulatory integrity are at the heart of the workplace culture.
What Remuneration Can You Expect from This Job?
As a Quality Assurance Specialist – Laboratory Diagnostics based in Dallas, TX, you can expect a competitive compensation package aligned with industry standards and your level of expertise. This role offers both stability and growth potential in a regulated, high-impact healthcare environment. Here’s what you can typically expect in terms of remuneration:
1. Base Salary
The base salary for a Quality Assurance Specialist in the laboratory diagnostics field typically ranges from $65,000 to $95,000 per year, depending on your experience, qualifications, and the complexity of the role. Candidates with specialized certifications or significant regulatory experience may command salaries on the higher end of this range.
2. Performance-Based Bonuses
Many employers offer annual performance bonuses tied to quality metrics, audit outcomes, operational improvements, and regulatory compliance success. These bonuses typically range from 5% to 15% of the base salary and reward consistent performance and results.
3. Health and Wellness Benefits
You can expect a comprehensive benefits package that includes:
Medical, dental, and vision insurance
Health savings accounts (HSA) or flexible spending accounts (FSA)
Mental health support and wellness programs
Paid sick leave and short-term disability coverage
4. Retirement and Financial Benefits
Most companies provide access to 401(k) retirement plans, often with company matching contributions. Some employers may also offer financial planning support, life insurance, and long-term disability coverage as part of the benefits package.
5. Paid Time Off and Work-Life Balance
The role typically includes generous paid time off (PTO), including vacation, personal days, and holidays. Many employers in the diagnostics sector also support flexible work arrangements and a focus on work-life balance.
6. Continuing Education & Certification Support
To support career development, companies often offer tuition reimbursement or funding for certification programs, including CAP, CLIA, ISO training, or Six Sigma credentials.
Total Compensation Potential
When combined, your base salary, bonuses, benefits, and professional development support can create a total annual compensation package ranging from $75,000 to $110,000 or more, depending on company policies and individual performance.
How to Apply
If you are a detail-oriented professional with a strong background in quality assurance, regulatory compliance, and laboratory diagnostics, we encourage you to apply for the Quality Assurance Specialist – Laboratory Diagnostics position in Dallas, TX. This role offers an exciting opportunity to contribute to a mission-driven organization focused on delivering high-quality diagnostic solutions.
To apply, please submit your updated resume and a brief cover letter highlighting your experience in:
Quality assurance within clinical or diagnostic laboratories
Regulatory standards such as CLIA, CAP, ISO 13485, or FDA
Internal audits, documentation control, and process improvement
Cross-functional collaboration and maintaining compliance
Root cause analysis and corrective/preventive action (CAPA) implementation
This position is ideal for individuals who are passionate about improving healthcare outcomes through meticulous quality systems and compliance. Join a collaborative team where your expertise will help shape the future of diagnostic excellence.
Apply now to take the next step in your career as a Quality Assurance Specialist – Laboratory Diagnostics in Dallas, TX!
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Quality Assurance Specialist | Laboratory Diagnostics Jobs | CLIA Compliance | CAP Accreditation | ISO 13485 | QA in Healthcare | Regulatory Affairs | Clinical Lab Quality | Dallas Healthcare Careers | Diagnostic Lab Jobs
