Quality Manager

About Orange Health Labs
Orange Health Labs is revolutionizing the diagnostic healthcare sector in India by making diagnostic testing more convenient, reliable, and faster. Founded in 2020, the company has quickly grown into one of the top-10 diagnostic brands across major metro cities like Bangalore, Delhi, Mumbai, and Hyderabad. With over 900 dedicated team members—proudly referred to as O-Rangers—and more than 1 million customers served, Orange Health Labs has established itself as India’s highest-rated diagnostic lab. Backed by prominent investors such as Accel, Bertelsmann India, General Catalyst, and Y Combinator, we are committed to making diagnostics a seamless and trusted part of every healthcare journey.

About the Role – Quality Manager
Orange Health Labs is seeking a highly experienced Quality Manager to lead the development, implementation, and management of its Quality Management System. In this critical leadership role, you will ensure that all laboratory processes adhere to the highest regulatory and quality standards, such as CLIA, CAP, and ISO 15189:2022. As a key contributor, you will oversee quality assurance and control activities, lead audits, address non-conformities, and spearhead continuous improvement initiatives. This role is pivotal to ensuring that our diagnostic services remain fast, accurate, and reliable, ultimately improving healthcare outcomes for millions of families across India.

Join us to make diagnostics 10x more efficient and impactful while being part of a vibrant, customer-centric team rated highly for its employee engagement and culture.

1. Develop and Maintain the Quality Management System (QMS)

• Design and implement a robust QMS to ensure compliance with regulatory standards (e.g., ISO 15189:2022).
• Regularly review and update quality policies, procedures, and documentation to reflect changes in regulations and industry practices.
• Ensure all laboratory processes and workflows align with QMS requirements.

2. Regulatory Compliance

• Monitor and ensure adherence to all applicable regulatory standards.
• Prepare the lab for internal and external audits and inspections by regulatory bodies.
• Keep up-to-date with changes in regulations and adapt laboratory processes accordingly.

3. Quality Control (QC) Oversight

• Supervise the internal and external quality control programs to ensure the accuracy and reliability of diagnostic tests.
• Evaluate the precision of laboratory results and take corrective actions where needed.
• Oversee documentation, review quality control logs, and ensure timely reporting of results.

4. Audits and Inspections

• Lead preparation for external audits by accrediting bodies (e.g., ISO or CAP).
• Facilitate internal audits to identify gaps or non-conformities in processes.
• Address non-conformances identified during audits and implement corrective and preventive actions (CAPA).

5. Training and Staff Competency

• Provide regular training to laboratory staff on quality standards, protocols, and regulatory requirements.
• Develop training materials to enhance staff understanding of quality management practices.
• Evaluate and ensure competency of staff in quality assurance processes.

6. Continuous Improvement

• Analyze quality data to identify trends, gaps, or inefficiencies in laboratory operations.
• Lead initiatives to improve quality, efficiency, and turnaround time (TAT).
• Foster a culture of continuous improvement by encouraging innovative solutions.

7. Documentation and Reporting

• Ensure proper documentation of all quality-related activities, including test validations, QC results, and audit findings.
• Maintain detailed records to demonstrate compliance during inspections.
• Generate reports for internal stakeholders to showcase quality performance metrics.

8. Root Cause Analysis

• Investigate errors, non-conformances, and customer complaints to identify root causes.
• Develop and implement corrective and preventive action plans to address identified issues.
• Monitor the effectiveness of CAPA actions over time.

9. Metrics Monitoring

• Track and evaluate key performance metrics such as Turnaround Time (TAT) and Quality Management Metrics to measure efficiency and service quality.
• Use these metrics to implement strategies that maintain or exceed quality standards.

10. Foster a Culture of Quality

• Encourage a lab-wide commitment to high standards in every task and process.
• Promote teamwork and accountability across the organization for quality assurance.

Job Responsibilities

As the Quality Manager, your primary responsibilities include:

1. Quality Management System (QMS)

• Develop, implement, and maintain the laboratory’s Quality Management System in compliance with standards such as CLIA, CAP, and ISO 15189:2022.
• Ensure all laboratory processes, protocols, and procedures meet the highest quality and regulatory standards.
• Regularly review and update quality policies and documentation.

1. Regulatory Compliance

• Ensure full compliance with applicable regulations and industry best practices.
• Prepare for and facilitate internal and external audits/inspections, including CAP, ISO, and other accrediting bodies.
• Address audit findings with effective corrective and preventive action plans (CAPA).

1. Quality Control and Assurance

• Monitor the accuracy, reliability, and precision of laboratory tests.
• Oversee internal and external quality control (QC) programs to identify and resolve deviations.
• Analyze QC data, document results, and implement corrective measures as necessary.

1. Staff Training and Competency

• Provide ongoing training to lab staff on quality standards, processes, and compliance protocols.
• Ensure staff competency in quality management and regulatory compliance.
• Develop and maintain training materials and evaluations.

1. Audits and Reporting

• Plan, execute, and oversee internal audits to evaluate lab performance and compliance.
• Document audit results, generate quality performance reports, and present them to leadership.

1. Process Improvement

• Analyze quality metrics such as Turnaround Time (TAT) and lab efficiency data to identify areas for improvement.
• Implement continuous improvement initiatives to enhance lab performance and customer satisfaction.

1. Leadership and Collaboration

• Work closely with cross-functional teams (operations, technical, and customer support) to ensure quality alignment.
• Foster a culture of accountability, excellence, and continuous learning within the laboratory team.

Qualifications

To qualify for this role, you should meet the following requirements:

• Education:

• A Bachelor’s degree in Medical Technology, Clinical Laboratory Science, Biomedical Science, or a related field.

• An advanced degree (e.g., MSc, MHA, or MBA) is preferred but not mandatory.

• Certifications:

• Certification in quality management or assurance (e.g., ASQ Certified Manager of Quality/Organizational Excellence, Six Sigma, or Lean certifications) is a plus.

• Experience:

• A minimum of 8 years of experience in a clinical laboratory or diagnostic setting.
• At least 6 years in a quality management role, with a strong track record of implementing and managing QMS and achieving regulatory compliance.

Skills and Competencies

To succeed in this role, you should possess the following skills:

1. Technical and Industry Knowledge:

• In-depth understanding of regulatory standards such as CLIA, CAP, and ISO 15189:2022.
• Expertise in quality control (QC) and assurance practices, including laboratory audits and inspections.

1. Analytical and Problem-Solving Skills:

• Ability to identify root causes of non-conformances and implement corrective/preventive actions.
• Strong data analysis skills to interpret quality metrics and improve processes.

1. Leadership and Training Skills:

• Proven ability to lead teams and foster a culture of quality excellence.
• Experience in designing and delivering training programs on quality standards and processes.

1. Communication and Collaboration:

• Excellent communication skills to interact with regulatory bodies, lab staff, and leadership.
• Strong interpersonal skills to collaborate effectively across departments.

1. Technical Tools and Software:

• Proficiency in using quality management software and laboratory information systems (LIS).
• Familiarity with tools like Excel, Power BI, or other data visualization platforms.

Why This Role is Important

The Quality Manager is a key player in ensuring the accuracy, reliability, and compliance of Orange Health Labs’ diagnostic services. By maintaining stringent quality standards, you’ll directly contribute to delivering a WOW customer experience, fostering trust in our brand, and improving healthcare outcomes for millions of families.

If you are a passionate professional with a strong background in quality management and a desire to make a significant impact in the healthcare diagnostics industry, this is the perfect opportunity for you. Join Orange Health Labs, where we are redefining diagnostics with speed, accuracy, and reliability. Together, we can transform healthcare outcomes and become the trusted diagnostic brand for families across India.

We look forward to welcoming a dedicated Quality Manager to our dynamic and innovative team!