Test Lead - Automation

The Senior Quality System Engineer is responsible for the day to day management of the electronic quality management systems and driving process improvement initiatives across the quality organization.

This position collaborates closely with Post Market Quality Complaints, Enterprise Systems, Operations,Supplier Quality, and Quality Assurance.

As part of our team, your core responsibilities will be:

1. Quality Management System:

- Service as the Administrator for all Quality management Systems.

- Responsible for implementation, lifecycle management, maintenance and configuration ofeQMS, in accordance with change control processes.

- Assess implementations, updates and upgrades to eQMS to determine the need for revalidation; coordinate internal revalidation activities.

- Translate User Requirements into Functional Requirements.

- Coordinate, create and/or execute validation activities including, but not limited to

Planning, Requirements, Protocols, UAT.

- Coordinate and lead projects related to the Butterfly eQMS:

- Collaborate with cross-functional process owners and stakeholders to configure quality

process modules to enhance compliance and efficiency.

- Continuously gather feedback to ensure the eQMS continues to meet the needs of the organization and

is scaling appropriately.

- Responsible for troubleshooting and resolving eQMS issues.

- If required, record and report issues to the vendor and see them through resolution

2. CAPA/NCE Management:

- Lead investigations of assigned CAPAs/NCEs

3. Audit Coordination: - Support and manage (as assigned) the internal and external audits to evaluate the adherence to

quality standards, regulations, and QMS procedures.

4. Document Control:

- Oversee the management of QMS documentation and records in Omnify, ensuring accuracy,

version control, and compliance with document control procedures.

5. General Quality Affairs Support:

- Perform a broad variety of tasks in support of the role and responsibilities including, but not limited

to:

- Responsible for performing gap assessments to plan Quality Objectives and improvement

initiatives

- Responsible for contributing to the continual quality of Butterfly Networks process

improvement initiatives.

- Ensuring that policies, procedures and practices are in compliance with global regulatory

requirements and are aligned with our Quality Policy.

- Responsible for performing tasks to support the quality system and quality policy as

directed by QA management including, but not limited to Quality Review Board,

Management Review and supporting internal/external audits.

Qualifications

Baseline skills/experiences/attributes:

- Bachelor's degree

- 5-7 years of experience in medical device quality management.

- Strong knowledge of quality management principles, methodologies, and relevant regulations (e.g.,

FDA, ISO, GMP).

- Proficiency in electronic Quality Management Systems.

- Demonstrated experience in leading and participating in internal and external audits.

- Excellent analytical, problem-solving, and communication skills.

- Ability to build and maintain cross-functional working relationships.

Ideally, you also have these skills/experiences/attributes (but its ok if you dont!):

- Certification in Quality Management (e.g., Certified Quality Auditor) is a significant advantage