Alcon - Manager II - Digital Health Quality Assurance

Job Description:

Alcon is seeking a highly motivated and experienced Manager II, Digital Health QA to lead Quality Assurance efforts for our growing portfolio of digital health products.

This position plays a critical role in ensuring the quality, compliance, and regulatory readiness of software-based medical solutions, including mobile apps, cloud platforms, and AI-driven tools that support vision care and eye health.

As the QA Manager, you will be responsible for developing and managing quality processes specific to digital product development in alignment with global regulatory standards such as ISO 13485, FDA 21 CFR Part 11, and IEC 62304.

You will collaborate closely with cross-functional teams including R&D, Regulatory, Clinical, and IT to drive a culture of continuous improvement and ensure that Alcons digital health offerings meet the highest standards of safety and efficacy.

Key Responsibilities:

- Lead and manage the Digital Health QA team across global locations.

- Establish and maintain software validation and verification processes.

- Provide quality oversight for the development lifecycle of digital health solutions.

- Conduct audits and ensure compliance with internal and external quality standards.

- Represent QA in cross-functional project meetings and regulatory submissions.

- Support risk management and CAPA activities for digital products.

Qualifications:

- Bachelors degree in Engineering, Life Sciences, or related field (Masters preferred).

- 8+ years of experience in Quality Assurance, with at least 3 years in digital health or software as a medical device (SaMD).

- Strong knowledge of digital health regulations and standards.

- Demonstrated leadership and team management skills.

Alcon is proud to be an Equal Opportunity Employer, celebrating diversity and committed to fostering an inclusive workplace for all employees