Staftonic LLC · 1 day ago
QA Specialist
Lowell, MA
Contract
Hybrid
Senior Level, Lead/Staff
8+ years expStaftonic LLC is supporting a client developing Class II and Class III medical devices that are entering expanded clinical trials. They are looking for an experienced Clinical Quality / Medical Device Quality professional with strong GCP and ISO 13485 expertise. The role involves leading clinical quality strategy, ensuring GCP compliance, and collaborating with various stakeholders.
Information Technology & Services
No H1B
Hiring Manager
Venkat Yeluri
Responsibilities
Lead clinical quality strategy and ensure GCP compliance
Support and oversee CROs and clinical vendors
Guide Design Controls and DHF implementation
Develop and execute risk-based clinical quality plans
Review and manage CAPAs from audits, deviations, and inspections
Collaborate with internal and external stakeholders
Qualification
Required
8+ years in Medical Device Quality (ISO 13485, GCP)
5+ years in clinical or pre-commercial products
Onsite presence minimum 3 days/week
Willingness 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