Staftonic LLC · 1 day ago
Clinical Quality Assurance Specialist
Massachusetts, United States
Contract
Onsite
Senior Level, Lead/Staff
8+ years expStaftonic LLC is seeking a Clinical Quality Assurance Specialist to provide leadership for medical device clinical trials. The role involves guiding clinical quality strategy, ensuring compliance with GCP and ISO 13485, and supporting oversight of CROs and clinical vendors.
Information Technology & Services
Hiring Manager
Shaik Aleem
Responsibilities
Provide clinical quality leadership for medical device clinical trials in compliance with GCP and ISO 13485
Guide and support clinical quality strategy for assigned programs
Ensure proper implementation and maintenance of design controls and Design History Files (DHF)
Develop and execute risk-based clinical quality plans
Support oversight and management of CROs and clinical vendors
Identify, assess, and remediate clinical quality risks and issues
Review and evaluate CAPAs arising from audits, deviations, and inspections
Perform CAPA effectiveness checks
Support internal and external audits and inspections
Collaborate with cross-functional stakeholders including Clinical, R&D, Regulatory, and Quality teams
Support global clinical activities , including international travel as required (Israel/India)
Qualification
Required
8+ years of experience in Quality Assurance within the medical device industry
5+ years of hands-on experience with GCP and pre-commercial medical devices
Strong knowledge of GCP (Good Clinical Practice)
Strong knowledge of ISO 13485
Strong knowledge of Design Controls & DHF
Strong knowledge of CAPA management
Strong knowledge of clinical audits and inspections
Proven experience working with Class II and Class III medical devices
Experience managing or supporting CROs and clinical vendors
Ability to work on-site at least 3 days per week
Willingness and ability to travel internationally
Company
Staftonic LLC
At Staftonic, we believe in turning possibilities into realities.
11-50 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase