Manager II, Digital Health QA

Position Summary:

The Manager II, Digital Health Quality plays a critical role in ensuring the quality, integrity, and regulatory compliance of software used in medical devices (SiMD) and Software as a Medical Device (SaMD). This role provides both strategic and hands-on leadership across all software quality assurance (SQA) activities and manages a team of local Software Quality Associates. The position spans the entire software lifecycle—from development through deployment and ongoing operations—and ensures conformance with internal policies, industry standards, and global regulations.

Key Responsibilities:

Team Leadership & Development

• Lead, mentor, and manage a team of local Software Quality Associates.
• Provide training and continuous development to ensure high performance and alignment with evolving quality and regulatory expectations.

Quality Assurance Oversight

• Act as the lead SQA for assigned software projects and initiatives.
• Provide quality oversight across all phases of the Software Development Life Cycle (SDLC), including planning, development, testing, deployment, and operational support.
  • Ensure adherence to both Agile (e.g., sprints) and Waterfall methodologies.
  • Support quality activities related to production deployments, release readiness, and post-release monitoring.
• Participate in bug triage and prioritization, ensuring thorough and risk-based assessments of software defects and quality issues.

Documentation Review & Compliance

• Review and approve critical software documentation, including:
  • Development plans and design specifications
  • Software requirements and risk assessments
  • Test protocols, results, and traceability matrices
  • Deployment plans and change control records
• Ensure all documentation complies with Alcon’s quality system, global standards, and regulatory guidelines.

Stakeholder Collaboration

• Collaborate with the Software Quality Lead (Lake Forest) and global cross-functional stakeholders to coordinate software QA oversight and ensure high-quality deliverables.

Audit & Regulatory Support

• Prepare and support internal/external audits and inspections, including those by regulatory agencies, by ensuring timely access to compliant records and responses.

Computerized System Validation (CSV)

• Provide quality review and approval for the validation of software tools and systems used in regulated activities, following GAMP and CSA principles.

Issue & Complaint Management

• Contribute to complaint investigations related to software, helping identify root causes and implement corrective and preventive actions (CAPAs).

Performance Metrics & Continuous Improvement

• Assist in the collection, development, and reporting of key performance indicators (KPIs) to measure software quality performance.
• Identify and drive opportunities for process improvements to enhance software reliability, compliance, and team effectiveness.

Minimum Qualifications:

• Bachelor's degree in Engineering or a related technical discipline; or equivalent professional experience
• 5+ years of relevant experience in software quality assurance, preferably in the medical device industry
• Proven leadership and/or mentoring experience
• Strong working knowledge of applicable regulatory and quality standards for medical device software, including:
  • FDA 21 CFR 820 and 11
  • IEC 62304
  • ISO 13485
  • ISO 14971
  • FDA’s General Principles of Software Validation
• Ability to work independently, manage multiple projects, and deliver high-quality results in a remote or asynchronous environment
• Strong interpersonal and communication skills (written and verbal) in English
• Proficiency in Microsoft Office applications (Outlook, Excel, Word)
• Demonstrated understanding of data integrity in regulated environments

Preferred Qualifications:

• Hands-on experience with Agile/Scrum and Waterfall SDLC methodologies
• Familiarity with software deployment and operational quality considerations (e.g., release management, monitoring, incident response)
• Experience with Computerized System Validation (CSV), CSA, and GAMP frameworks
• Proficiency with software lifecycle tools such as Jira, Polarion, Azure DevOps, and Windchill PLM
• Experience conducting audits and internal investigations, including root cause analysis

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Alcon is an Equal Opportunity Employer and takes pride in maintaining a diverse environment. We do not 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 status, disability, or any other reason.