Job Requirements
Silver Spring, MD
Secret Polygraph not specified
Mid Level Career (5+ yrs experience)
Salary not specified
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Job Description
The QA Specialist supports and maintains the organization’s ISO 15189 Quality Management System, applying Lean Six Sigma methodologies to ensure regulatory compliance, operational efficiency, and continuous improvement. This role is responsible for audits, CAP ISO assessments, risk management activities, documentation control, and support of Laboratory Developed Testing (LDT) compliance.
Key Responsibilities:
Support implementation and continuous improvement of the ISO 15189 Quality Management System using Lean Six Sigma tools (DMAIC, FMEA, SPC, Value Stream Mapping).
Participate in CAP ISO assessments and manage nonconformance and corrective action tracking to ensure timely resolution.
Plan and conduct internal audits; document findings and follow up on corrective actions.
Perform risk assessments and assist in developing mitigation strategies.
Ensure compliance with regulatory requirements, including FDA regulations and LDT oversight.
Develop, update, and maintain quality policies, procedures, and document control systems.
Provide training to staff on ISO standards, quality tools, and compliance practices.
Prepare reports and quality metrics for leadership and support external audits and inspections.
Qualifications:
Bachelor’s degree in Quality Engineering, Quality Management, Business, or related field required; Master’s or PhD preferred.
Certified Quality Auditor (CQA) and Lean Six Sigma Green Belt or higher preferred
5–7 years of experience in ISO 15189 quality programs, auditing, CAP ISO assessments, and risk management.
Knowledge of FDA regulations and laboratory compliance standards preferred.
Proficiency with compliance software and audit management tools.
This role requires strong analytical skills, attention to detail, and a commitment to maintaining high standards of quality and regulatory compliance.
Key Responsibilities:
Support implementation and continuous improvement of the ISO 15189 Quality Management System using Lean Six Sigma tools (DMAIC, FMEA, SPC, Value Stream Mapping).
Participate in CAP ISO assessments and manage nonconformance and corrective action tracking to ensure timely resolution.
Plan and conduct internal audits; document findings and follow up on corrective actions.
Perform risk assessments and assist in developing mitigation strategies.
Ensure compliance with regulatory requirements, including FDA regulations and LDT oversight.
Develop, update, and maintain quality policies, procedures, and document control systems.
Provide training to staff on ISO standards, quality tools, and compliance practices.
Prepare reports and quality metrics for leadership and support external audits and inspections.
Qualifications:
Bachelor’s degree in Quality Engineering, Quality Management, Business, or related field required; Master’s or PhD preferred.
Certified Quality Auditor (CQA) and Lean Six Sigma Green Belt or higher preferred
5–7 years of experience in ISO 15189 quality programs, auditing, CAP ISO assessments, and risk management.
Knowledge of FDA regulations and laboratory compliance standards preferred.
Proficiency with compliance software and audit management tools.
This role requires strong analytical skills, attention to detail, and a commitment to maintaining high standards of quality and regulatory compliance.
group id: 10115448
