65 applicants

Company

Original Job Post

Alcon · 2 days ago

Director of Data Quality Engineering

United States

Full-time

Remote

Director

12+ years exp

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Responsibilities

Build and implement automated testing processes to improve efficiency and reliability.

Ensure that data used in medical devices meets regulatory standards and is validated.

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.

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

Ensure compliance with regulatory requirements.

Handle non-conformance reports (NCRs) promptly.

Create and implement strategy for Data Lifecycle management

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.

Qualification

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Quality EngineeringComplianceTest AutomationV&VSaMDDatabase TechnologiesData WarehousesData Engineering TechnologiesPublic CloudsCompliance & Regulatory RequirementsData PrivacyData SecurityHIPAAGDPRCCPAFDA CybersecuritySecurity FrameworksInteroperability Data StandardsHealthcareTest Automation ToolsTosca-QtestLeadershipCommunicationCollaboration

Required

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