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SiPhox Health · 9 hours ago

Quality Specialist

Burlington, MA

Full-time

Onsite

Mid Level

3+ years exp

SiPhox Health is creating an entirely new category of at-home technology that brings advanced biological measurement into everyday life. As a Quality Specialist, you will own the day-to-day execution and continuous improvement of the Quality Management System (QMS) while collaborating with engineering, operations, and clinical teams to ensure compliance with regulatory standards.

Health CareHealth DiagnosticsMedical Device

No H1B

Hiring Manager

Diedrik Vermeulen

Responsibilities

Own document and record control within the ISO 13485 QMS, including creation, review, approval, release, revision, archival, and change control of controlled documents and quality records

Administer and maintain the training program, including onboarding, role-based training, QMS training, and training effectiveness tracking to ensure ongoing compliance

Administrates Corrective and Preventive Action (CAPA) activities, including issue intake, investigations, root cause analysis, action planning, implementation, and effectiveness verification

Partner cross-functionally with engineering, operations, and scientific teams to interpret and apply QMS requirements in a pragmatic, scalable way that supports rapid development without compromising compliance

Develop, review, and continuously improve SOPs and quality system documentation, ensuring alignment with applicable regulations and standards and supporting adoption through clear communication and change management

Track, analyze, and report key quality metrics and trends, using data to drive visibility, risk mitigation, and continuous improvement initiatives

Support post-market surveillance and adverse event reporting activities, including complaint handling, documentation, investigation support, and timely escalation and follow-through as required

Support internal and external audits and inspections, including preparation, participation, response coordination, and follow-up actions

Participate in risk management activities, including risk assessments, hazard analyses, and linkage of risk controls to design, process, and post-market activities

Qualification

ISO 13485 QMSQuality Management SystemFDA submissionsIn-vitro Diagnostic developmentRisk managementCommunication skillsCollaborationProblem-solving

Required

At least 3 years of experience working in an ISO 13485 QMS environment

At least 2 years of experience in a fast-moving medical device start-up environment

Strong written and verbal communication skills; able to collaborate effectively across disciplines

Excellent understanding of ISO 13485 and its practical application

Bachelor's degree in a relevant field

Ability to travel as required (<10%)

Authorized to work in the U.S. without sponsorship

Preferred

Experience with In-vitro Diagnostic (IVD) development and manufacturing

Supporting FDA submissions, including 510(k)s and/or De Novo applications (e.g., reviewing submission documentation, establishing Design History Files, responding to quality related questions, etc.)

Participation in internal and supplier auditing programs, as well as supporting the organization during ISO 13485 and FDA audits