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Pragmatic · 4 hours ago

Senior Quality Engineer

Bedford, MA

Full-time

Onsite

Mid, Senior Level

$120K/yr - $140K/yr

4+ years exp

Pragmatic is a growing medical device company seeking a Senior Quality Engineer to play a critical role in product development. The role focuses on design quality and involves collaborating with R&D to ensure products meet safety and regulatory standards.

Staffing & Recruiting

Growth Opportunities

Hiring Manager

Jay Hine

Responsibilities

Act as the Quality lead on design and development projects

Own and support design controls , including:

Risk management (FMEA, hazard analysis)

Design inputs and outputs

Design reviews

Verification and validation activities

Partner with R&D to ensure products are designed for patient safety, regulatory compliance, and quality by design

Support sterility and biological testing and validation as required

Help develop, implement, and improve the Quality Management System (QMS)

Ensure compliance with FDA cGMP, ISO 13485, and EU MDR

Support and participate in FDA and Notified Body audits

Conduct internal and external audits

Support CAPA activities, complaint handling, and supplier quality

Provide technical leadership and mentorship to Quality Engineers and junior team members

Qualification

Design controlsRisk managementVerificationValidationFDA complianceISO 13485EU MDRASQ certificationsCommunication skillsProblem-solving skillsOrganizational skills