Product Complaint Specialist II (Medtech)

TL;DR

Product Complaint Specialist II (Medtech): Managing and documenting customer complaints and feedback for products and services with an accent on ISO 9001 and 13485 standards. Focus on coordinating the Field Action process from initial assessment through closure and ensuring strict regulatory compliance.

Location: Hybrid; must be based in Rockville or Gaithersburg, Maryland, USA

Salary: $78,100 – $116,200 per year

Company

hirify.global is a developer of high-performance diagnostic platforms for the life sciences and clinical markets.

What you will do

• Document and manage customer complaints and feedback in accordance with internal and regulatory procedures.
• Ensure all processes align with ISO 9001 and ISO 13485 standards.
• Oversee the Field Action process from the initial assessment phase through to formal closure.
• Communicate and exchange technical information with relevant stakeholders to resolve product issues.
• Maintain comprehensive records to meet applicable regulatory requirements.

Requirements

• Must be based in the USA (specifically Rockville or Gaithersburg, MD).
• Experience working with ISO 9001 and ISO 13485 standards.
• Proven ability to manage regulatory documentation and compliance processes.
• Strong communication skills for effective information exchange in a professional environment.

Culture & Benefits

• Comprehensive medical, dental, and vision coverage, including prescription benefits.
• 401(k) plan with company matching.
• Paid vacation, sick leave, holidays, and parental leave.
• Flexible spending accounts and company-paid short- and long-term disability insurance.
• Additional perks including fitness club membership contributions and pet insurance.