Overview
Quality Manager Jobs in Weldon, NC at Patch Rubber Company
About us
Eccolab Group is a licensed, independent full-service clinical laboratory headquartered in Miami, Florida, with additional facilities in Tampa. Established in 2001, we provide comprehensive analytical services to a diverse clientele, including hospitals, skilled nursing facilities, assisted living centers, and research organizations. With a strong focus on accuracy, innovation, and client education, we are committed to improving patient outcomes through fast, reliable diagnostics and cutting-edge laboratory technologies. Our team upholds the highest standards in quality assurance, compliance, and customer service. Visit us at eccolabgroup.com for more information.
Position Summary
The Quality Assurance (QA) Technical Lead is responsible for ensuring that all clinical laboratory processes, procedures, and documentation meet established quality standards and comply with regulatory requirements. This role plays a critical part in monitoring and maintaining the integrity of clinical operations by conducting audits, identifying areas of non-compliance, implementing corrective actions, and driving continuous improvement initiatives. The QA Specialist collaborates closely with the clinical laboratory personnel, supervisors, and management to uphold quality performance, ensure accurate reporting, and support accreditation standards. Attention to detail, analytical thinking, and a strong understanding of clinical laboratory protocols are essential to the success of this role.
Scope
The Quality Assurance (QA) Technical Lead serves as a key leadership figure in a high-complexity clinical laboratory environment, responsible for driving compliance, regulatory readiness, and continuous improvement across all operational functions. This role is deeply embedded in the lab’s day-to-day processes, with the authority to intervene in non-conforming activities, lead root cause investigations, and implement corrective actions that align with CAP, CLIA, COLA, and OSHA standards.
Reporting directly to senior laboratory leadership, the QA Technical Lead manages the laboratory’s quality management system, including internal audits, document control, incident reporting, and proficiency testing compliance. The position plays an essential role in preparing for and navigating external inspections, ensuring that all processes meet or exceed regulatory expectations and accreditation benchmarks.
This individual partners closely with Technical Supervisor, clinical technologists, and department supervisors to cultivate a strong culture of quality, safety, and accountability. The ideal candidate brings a deep understanding of clinical laboratory workflows and demonstrates the ability to translate regulatory requirements into practical, operational excellence—ensuring the highest standard of patient testing and laboratory performance.
Job Responsibility
Develop, implement, and maintain the laboratory’s Quality Management System (QMS) in alignment with COLA, CLIA, OSHA, and other applicable regulatory standards.
Conduct internal quality audits, identify areas of non-compliance, and track corrective and preventive actions (CAPA) to resolution.
Monitor and maintain documentation control procedures, ensuring accuracy, version control, and compliance with regulatory requirements.
Review and approve standard operating procedures (SOPs) and ensure staff adherence through training and routine checks.
Oversee proficiency testing processes, monitor performance data, and investigate discrepancies to ensure accurate and reliable testing outcomes.
Lead root cause analyses for quality incidents or deviations and collaborate with department leads to implement corrective actions.
Prepare and support regulatory inspections and accreditation surveys (e.g., COLA, CLIA), ensuring full readiness and documentation integrity.
Maintain quality metrics dashboards and provide regular reports to leadership on compliance trends, risks, and improvement opportunities.
Facilitate training on quality and compliance protocols for laboratory personnel to reinforce a culture of accountability and excellence.
Serve as the primary liaison for quality assurance-related communication between internal departments and external regulatory bodies.
Oher assigned duties
Key Requirements
COMPLIANCE
Program Management: implement and maintain a quality assurance program to evaluate lab services, applying Lean practices to identify risk and improve outcomes.
QA/QC Monitoring: oversee internal QA/QC processes including SOP design, detection limits, data quantification, and documentation review.
Statistical Review: use statistical methods to assess data accuracy, reporting integrity, and documentation compliance.
LIS Support: assist the LIS Administrator to ensure data quality within the Laboratory Information System.
System Audits: review quality systems for adherence to the QA manual and applicable certification requirements.
System Updates: work with lab management to address non-compliance and revise systems to support continuous improvement.
Regulatory Familiarity: maintain current knowledge of CLIA, COLA, and state/federal regulations affecting laboratory operations.
Standards Interpretation: interpret national regulations and integrate them into the lab’s quality management and safety practices.
Compliance Documentation: support staff in documenting compliance using structured data tools aligned with regulatory bodies.
Proficiency Testing: coordinate and monitor documentation for all proficiency testing programs to maintain lab accuracy.
SAFETY
Safety Leadership: act as the Laboratory Safety Officer to ensure security and safety protocols are enforced and updated as required.
Incident Oversight: document incidents, lead follow-ups, and ensure corrective action plans are implemented.
Committee Coordination: lead quarterly Safety Committee meetings to address ongoing safety concerns.
Safety Audits: conduct safety reviews and represent the lab in monthly departmental safety meetings.
OPERATIONS
Audit Development: assist the Operations Manager in building internal audit systems for budgeting, billing, and procurement oversight.
Client Relations: support customer satisfaction by providing timely information and participating in on-site visits when necessary.
System Improvement: participate in L-SIP and partner with stakeholders to implement lab-wide quality improvements.
Funding Support: contribute to quality-related funding proposals and improvement initiatives.
Cross-Program Coordination: collaborate across programs (e.g., emergency response, epidemiology) to align lab operations with broader public health goals.
Qualifications
Experience: Minimum 2–4 years of experience in a clinical laboratory or healthcare QA/QC role, with demonstrated knowledge of quality systems, regulatory compliance, and audit preparation.
Education: Bachelor’s degree in medical laboratory science, Biology, Chemistry, or a related scientific or healthcare field required. Advanced degree or certification in Quality Management is a plus.
Regulatory Knowledge: Strong understanding of CLIA, COLA, CAP, OSHA, and other relevant laboratory accreditation and regulatory standards.
Technical Skills: Proficiency in Laboratory Information Systems (LIS), data analysis, document control platforms, and Microsoft Office Suite (especially Excel for tracking and metrics).
Analytical Thinking: Ability to perform root cause analyses, interpret complex regulations, and recommend practical, compliant solutions.
Communication: Strong written and verbal communication skills; capable of drafting SOPs, audit reports, and training documentation.
Attention to Detail: High level of accuracy in documentation, reporting, and process monitoring.
Training & Leadership: Experience facilitating staff training, leading audits, or participating in safety and quality committees is preferred.
Certifications (preferred but not required): ASCP, CQA (Certified Quality Auditor), or other relevant laboratory or quality assurance certifications.
Skills
Technical Skills: Proficient in data entry software and database management systems, with a strong aptitude for quickly learning and adapting to new technologies.
Attention to Detail: High level of accuracy in specimen handling, data entry, and documentation.
Organizational Skills: Ability to manage multiple priorities while maintaining organization and meeting deadlines.
Communication Skills: Strong verbal and written communication for accurate reporting and effective collaboration.
Regulatory Knowledge: Understanding of applicable healthcare regulations, including HIPAA, OSHA, and DOH standards.
Health & Safety Awareness: Commitment to maintaining a safe laboratory environment and adhering to safety protocols.
Problem-Solving: Capable of identifying and resolving minor equipment and testing issues independently.
Adaptability: Comfortable working under pressure in a fast-paced and evolving laboratory setting.
Team Collaboration: Works well with others in a multidisciplinary setting; cooperative and dependable.
Confidentiality: Strict adherence to patient privacy laws and ethical handling of sensitive data.
Bilingual Communication – Fluent in both English and Spanish; able to communicate effectively with diverse teams and stakeholders.
Charismatic Leadership – Motivated, approachable, and confident with a “lead by example” mindset that inspires team accountability.
Self-Starter – Proactive and disciplined, able to take initiative and drive improvements without constant supervision.
Positive Attitude & Energy – Brings high energy and optimism to the workplace, fostering a collaborative and solutions-focused environment.
Applicants must be legally authorized to work in the United States at the time of hire.
Job Types: Full-time, Contract, Permanent
Pay: $60,000.00 – $65,000.00 per year
Benefits:
Dental insurance
Health insurance
Paid time off
Vision insurance
Schedule:
8 hour shift
Day shift
Work Location: In person
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Title: Quality Manager
Company: Patch Rubber Company
Location: Weldon, NC
