Complaints Handler-Med Device

Edge Staffing; Boston (MA); Híbrido; USD 96.000 - 124.000; Jornada completa

Descripción de la vacante

Edge Staffing Limited is seeking a Senior QMS Complaints Specialist for a 3–6 month contract in the Greater Boston area. Hybrid role requiring 3 days onsite weekly, supporting a medical device client with high-impact quality and complaints remediation within a regulated environment.

The role focuses on reducing backlog, improving complaint handling processes, updating SOPs, and strengthening QMS workflows, while collaborating with Quality, Regulatory, Engineering, and Product teams to ensure

Formación

• 3–5+ years of medical device complaint handling experience
• Strong understanding of Quality Management Systems (QMS) and complaint workflows
• Experience with ISO 13485 and regulated medical device environments
• Background in SOP development, remediation, or process improvement
• Familiarity with adverse event reporting and regulatory expectations
• Strong analytical, communication, and organizational skills
• Ability to work independently and drive initiatives forward

Responsabilidades

• Lead efforts to reduce and remediate complaint backlog within the QMS
• Evaluate and optimize complaint handling workflows, systems, and operational processes
• Review, update, and improve Complaints Management SOPs and related procedures
• Support adverse event and reportability assessments in alignment with regulatory requirements
• Ensure accurate intake, documentation, triage, investigation, and resolution of complaints
• Analyze complaint trends and identify opportunities for process improvement and risk reduction
• Partner cross-functionally with Quality, Regulatory, Engineering, and Product teams
• Support internal and external audits, ensuring inspection readiness and compliant documentation
• Assist with root cause investigations and corrective action activities

Conocimientos

QMS

Complaint handling

Analytical skills

Communication

Organizational skills

Independence

Descripción del empleo

Senior QMS Complaints Specialist (Contract)

Location: Greater Boston, MetroWest area, (Hybrid – 3 days onsite)

Duration: 3–6 Month Contract

Overview

The team at Edge has partnered with a Boston area client in their search for a Senior QMS Complaints Specialist with strong medical device experience to support a high-impact quality and complaints remediation initiative within a regulated environment.

This role is focused on improving complaint handling processes, reducing backlog, enhancing SOPs, and helping optimize overall QMS workflows.

This is an ideal opportunity for a senior-level quality professional who can operate both strategically and hands-on within a fast-paced medical device organization.

Key Responsibilities

• Lead efforts to reduce and remediate complaint backlog within the QMS
• Evaluate and optimize complaint handling workflows, systems, and operational processes
• Review, update, and improve Complaints Management SOPs and related procedures
• Support adverse event and reportability assessments in alignment with regulatory requirements
• Ensure accurate intake, documentation, triage, investigation, and resolution of complaints
• Analyze complaint trends and identify opportunities for process improvement and risk reduction
• Partner cross-functionally with Quality, Regulatory, Engineering, and Product teams
• Support internal and external audits, ensuring inspection readiness and compliant documentation
• Assist with root cause investigations and corrective action activities

Required Qualifications

• 3–5+ years of medical device complaint handling experience
• Strong understanding of Quality Management Systems (QMS) and complaint workflows
• Experience working within ISO 13485 and regulated medical device environments
• Background in SOP development, remediation, or process improvement initiatives
• Familiarity with adverse event reporting and regulatory expectations
• Strong analytical, communication, and organizational skills
• Ability to work independently and drive initiatives forward

Additional Information

• Hybrid role requiring onsite presence at least 3 days per week
• Hands-on interaction with products and engineering teams is part of the role
• Looking for someone who can assess current processes, recommend improvements, and help implement change effectively