Senior Design Quality Engineer
Job Description
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 Network’s 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 it’s ok if you don’t!):
? Certification in Quality Management (e.g., Certified Quality Auditor) is a significant advantage