Director of Data Quality Engineering – Digital Health Data & Analytics

at  Alcon

At Alcon, we aspire to lead the world in innovating life-changing vision products because when people see brilliantly, they live brilliantly. As a global leader in eye care, we believe in innovating, especially through cutting edge technology. We are on a journey to offer the widest array of eye care and eye health offerings with products that can treat the entire eye at each stage of life.
Our Digital Health team is harnessing technology to build a leading portfolio of digital health solutions that will transform the eye care experience for medical professionals to patients and enable improved patient outcomes – from a predictive health care delivery platform harnessing ML and analytics to innovative medical device software.

As the Director of Data Quality Engineering, you will play a critical role in ensuring the accuracy, integrity, reliability, and compliance of our organization’s data and AI products and platform. Your responsibilities span across data quality management, governance, automation, and regulatory and privacy compliance. You will work closely with software platform architects, data architects, product, and engineering team. We are a fast-growing team, which will give you the opportunity to shape our ways of working and culture - think start-up, but inside a global leader in eye care. We are looking for someone who is a strategic thinker and problem solver.

• Data Quality Management:
• Build and implement automated testing processes to improve efficiency and reliability.
• Ensure that data used in medical devices meets regulatory standards and is validated.
• Data Governance:
• Develop and maintain data governance policies, procedures, and guidelines.
• Establish data ownership, stewardship, and accountability frameworks.
• Ensure compliance with data privacy regulations (e.g., HIPAA - ePHI, GDPR) and Software as Medical Device (SaMD) regulations (eg. ISO13485, IEC62304, 21CFR part11).
• Work closely with the Enterprise privacy and security teams to define data privacy and security testing methodologies. Develop and implement necessary technologies, policies, and procedures to ensure compliance with regulatory requirements and standards such as HITRUST, HIPAA, GDPR, ISO, SOC-II, etc.
• Test Automation and Strategies:
• Hands on design, development and deployment of test automation frameworks for both platform and product testing. Extend enterprise testing center of excellence tools and methodologies to be adapted for data products
• Define strategies for efficient and effective test data products and platform automation.
• Incorporate testing practices within Agile development cycles to enable test driven development
• Compliance and Audits:
• Ensure compliance with regulatory requirements.
• Handle non-conformance reports (NCRs) promptly.
• Create and implement strategy for Data Lifecycle management
• Continuous Improvement:
• Drive continuous testing (CT) practices.
• Promote data quality and governance across the organization.
• Collaborate with the product team to translate user needs and business requirements into test cases. Provide inputs to architects and product teams from a testing perspective (e.g., ensuring that acceptance criteria are testable, appropriate hooks are built in as part of the solution to enable test automation)
• Ensure alignment with NFRs during design, development, and testing phases
• Create Dashboards for monitoring the health and quality of data products during and after development (in production)
• Build, manage, and mentor a team of high-performing test engineer talents (Onsite and Offshore)
• Foster a culture of creativity, collaboration, speed, innovation, and excellence while continuously elevating the quality and caliber of our engineering organization.
• Manage relationships with third-party technology vendors and data providers to ensure data quality, accuracy, and security.

Minimum Qualifications

• Bachelor’s degree in computer science, or a related technical discipline.
• Over 12 years of hands-on experience in Quality Engineering, Compliance & Test automation. Demonstrated experience in leading the Quality initiatives of large-scale and highly reliable cloud-based data platform solutions.
• 3+ years of experience handling V&V for SaMD - Software as a Medical Device.
• 8+ years of hands-on experience in two or more database technologies (e.g., MySQL, PostgreSQL, MongoDB) and data warehouses (e.g., Redshift, BigQuery, or Snowflake), as well as cloud-based data engineering technologies (e.g., Kafka, PubSub, Apache Airflow, Glue)
• Experience with public clouds such as AWS and Azure.
• Deep knowledge in Compliance & Regulatory requirements for medical devices
• Extensive experience in data privacy and data security-related regulatory requirements, such as HIPAA, GDPR, CCPA, FDA cybersecurity for medical devices, and related security frameworks (e.g., ISO, NIST, HITRUST, SOC II).
• Deep knowledge and experience in various interoperability data standards in healthcare (e.g., HL7, FHIR, c-CDA, DICOM).
• Experience in Test automation tools such as Tosca-Qtest
• Excellent leadership and communication skills, with the ability to collaborate effectively with cross-functional teams

Minimum Qualifications

• Bachelor’s degree in computer science, or a related technical discipline.
• Over 12 years of hands-on experience in Quality Engineering, Compliance & Test automation. Demonstrated experience in leading the Quality initiatives of large-scale and highly reliable cloud-based data platform solutions.
• 3+ years of experience handling V&V for SaMD - Software as a Medical Device.
• 8+ years of hands-on experience in two or more database technologies (e.g., MySQL, PostgreSQL, MongoDB) and data warehouses (e.g., Redshift, BigQuery, or Snowflake), as well as cloud-based data engineering technologies (e.g., Kafka, PubSub, Apache Airflow, Glue)
• Experience with public clouds such as AWS and Azure.
• Deep knowledge in Compliance & Regulatory requirements for medical devices
• Extensive experience in data privacy and data security-related regulatory requirements, such as HIPAA, GDPR, CCPA, FDA cybersecurity for medical devices, and related security frameworks (e.g., ISO, NIST, HITRUST, SOC II).
• Deep knowledge and experience in various interoperability data standards in healthcare (e.g., HL7, FHIR, c-CDA, DICOM).
• Experience in Test automation tools such as Tosca-Qtest
• Excellent leadership and communication skills, with the ability to collaborate effectively with cross-functional teams

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Alcon is an Equal Opportunity Employer and participates in E-Verify. Alcon takes pride in maintaining a diverse environment and our policies are not to discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital or veteran status, disability, or any other legally protected status. Alcon is also committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an email to alcon.recruitment@alcon.com and let us know the nature of your request and your contact information

• Data Quality Management:
• Build and implement automated testing processes to improve efficiency and reliability.
• Ensure that data used in medical devices meets regulatory standards and is validated.
• Data Governance:
• Develop and maintain data governance policies, procedures, and guidelines.
• Establish data ownership, stewardship, and accountability frameworks.
• Ensure compliance with data privacy regulations (e.g., HIPAA - ePHI, GDPR) and Software as Medical Device (SaMD) regulations (eg. ISO13485, IEC62304, 21CFR part11).
• Work closely with the Enterprise privacy and security teams to define data privacy and security testing methodologies. Develop and implement necessary technologies, policies, and procedures to ensure compliance with regulatory requirements and standards such as HITRUST, HIPAA, GDPR, ISO, SOC-II, etc.
• Test Automation and Strategies:
• Hands on design, development and deployment of test automation frameworks for both platform and product testing. Extend enterprise testing center of excellence tools and methodologies to be adapted for data products
• Define strategies for efficient and effective test data products and platform automation.
• Incorporate testing practices within Agile development cycles to enable test driven development
• Compliance and Audits:
• Ensure compliance with regulatory requirements.
• Handle non-conformance reports (NCRs) promptly.
• Create and implement strategy for Data Lifecycle management
• Continuous Improvement:
• Drive continuous testing (CT) practices.
• Promote data quality and governance across the organization.
• Collaborate with the product team to translate user needs and business requirements into test cases. Provide inputs to architects and product teams from a testing perspective (e.g., ensuring that acceptance criteria are testable, appropriate hooks are built in as part of the solution to enable test automation)
• Ensure alignment with NFRs during design, development, and testing phases
• Create Dashboards for monitoring the health and quality of data products during and after development (in production)
• Build, manage, and mentor a team of high-performing test engineer talents (Onsite and Offshore)
• Foster a culture of creativity, collaboration, speed, innovation, and excellence while continuously elevating the quality and caliber of our engineering organization.
• Manage relationships with third-party technology vendors and data providers to ensure data quality, accuracy, and security