Global Post-Market Surveillance & Complaints Lead

TSK Laboratory Europe B.V.; Arlington (WA); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Competitive salary based on experience

Health, dental, and vision insurance

401K retirement plan with company matching

Job summary

A global medical technology company is hiring a Post-Market Surveillance & Complaints Specialist in Arlington, Virginia. The role involves managing complaint handling and ensuring compliance with regulatory requirements for medical devices. The ideal candidate has a Bachelor’s degree and 3–5 years of experience in quality assurance or post-market surveillance in regulated environments. Join a fast-paced team focused on innovation and product safety.

Qualifications

• 3–5 years of experience in quality assurance or post-market surveillance.
• Experience in FDA-regulated and ISO 13485 environments.
• Proven ability to lead CAPA activities and conduct investigations.

Responsibilities

• Manage the full lifecycle of product complaints from intake to closure.
• Assess complaints for regulatory reportability and prepare necessary reports.
• Collaborate with cross-functional teams to resolve quality issues.

Skills

Technical writing

Root cause analysis

Communication

Data analysis

Problem-solving

Education

Bachelor’s degree in Engineering, Life Sciences, or related field

Tools

Data analysis tools

Job description

A global medical technology company is hiring a Post-Market Surveillance & Complaints Specialist in Arlington, Virginia. The role involves managing complaint handling and ensuring compliance with regulatory requirements for medical devices. The ideal candidate has a Bachelor’s degree and 3–5 years of experience in quality assurance or post-market surveillance in regulated environments. Join a fast-paced team focused on innovation and product safety.