About the job
Nature of the Job: Fully Remote
Job Summary:
The Program Manager - Development Quality Assurance plays a pivotal role in facilitating and refining the Device Development QA and Design Control processes within the Digital Medicine device group across all stages of the development lifecycle. This includes the requirements, design, and validation phases. As a key member of a cross-functional team, you will ensure that our device development process aligns with the highest quality standards set forth by the company’s medical device manufacturing and quality systems.
Responsibilities:
- Collaborate with engineers and development team members to ensure adherence to design controls in device manufacturing tool development.
- Establish and implement QA best practices to guarantee that products are developed with quality integrated into the design control process.
- Plan and execute verification activities, including document reviews and evaluations of designs, code, requirements, and specifications; actively contribute to process improvements.
- Assess resource needs and allocate appropriate resources to align with company priorities and objectives.
- Mentor and coach cross-functional teams on best practices and compliance with design control processes.
- Work closely with the Regulatory Department to ensure all regulatory requirements are met for documentation submissions.

