<h3>Job Description</h3>
Role: QA Specialist (Medical Device Industry) 
Location: Lowell, MA
 
Staftonic is supporting a client developing Class II and Class III medical devices that are entering expanded clinical trials. We are looking for an experienced Clinical Quality / Medical Device Quality professional with strong GCP and ISO 13485 expertise.
 
NOTE: ONLY W2 AND NEED ONLY FROM MEDICAL DEVICE MANUFACTURING INDUSTRY BACKGROUND
 
Key Responsibilities:
<ul>
<li>Lead clinical quality strategy and ensure GCP compliance</li>
<li>Support and oversee CROs and clinical vendors</li>
<li>Guide Design Controls and DHF implementation</li>
<li>Develop and execute risk-based clinical quality plans</li>
<li>Review and manage CAPAs from audits, deviations, and inspections</li>
<li>Collaborate with internal and external stakeholders</li>
</ul>
 
Requirements:
<ul>
<li>8+ years in Medical Device Quality (ISO 13485, GCP)</li>
<li>5+ years in clinical or pre-commercial products</li>
<li>Onsite presence minimum 3 days/week</li>
<li>Willingness to travel internationally.</li>
</ul>
Interested candidates may connect or message for details.