Quality Complaint Specialist

Overview

Investigate quality complaints, ensure regulatory compliance, support improvements.

Key Responsibilities

• regulatory reporting
• trend reporting
• audit readiness
• complaint investigation
• capa management
• trackwise utilization

Tasks

-Determine regulatory reportability and submit Medical Device Reports (MDRs) to the appropriate agencies. -Generate trend reports and metrics to identify recurring issues and support continuous improvement. -Support audit and inspection readiness by ensuring complaint files are complete and compliant. -Assist in the development of complaint closure letters and customer communications. -Conduct investigations into complaints, including root cause analysis and coordination with cross-functional teams such as R&D, Manufacturing, and Regulatory. -Participate in CAPA (Corrective and Preventive Action) activities related to complaint findings. -Collaborate with IT and other departments to ensure complaint handling systems, such as TrackWise, are properly utilized. -Maintain complaint records in accordance with internal procedures and regulatory standards.

Requirements

• detail oriented
• fda regulations
• trackwise
• microsoft office
• bachelor's
• 2-3 yrs

What You Bring

-High attention to detail and strong organizational skills. -Strong understanding of FDA regulations, ISO standards, and global complaint handling requirements. -Excellent written and verbal communication skills. -Proficiency in Microsoft Office and complaint management systems like TrackWise. -Ability to work independently and manage multiple priorities in a fast-paced environment. -Bachelor's degree in a scientific or related field such as Chemistry, Biology, or Nursing. -2–3 years of experience in complaint handling, quality assurance, or regulatory affairs within the medical device or pharmaceutical industry.

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Benefits

-Transportation benefits -Medical, dental & vision -Health Spending Account (HSA) -Short and long-term disability -Critical Illness, Accident, and Hospital -401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available -Employee Assistance Program -Life Insurance (Voluntary Life & AD&D for the employee and dependents) -Time Off/Leave (PTO, Vacation or Sick Leave)

About Actalent

-Born in July 2021 by merging Aerotek’s engineering & sciences arm with EASi, Actalent emerged as a focused engineering-and-science partner. -Backed by Allegis Group, it drives scale and speed to market via contract, managed, and technical services. -Headquartered in Maryland with global reach, it deploys specialized teams across North America, Europe, and APAC on Fortune 500 projects. -Typical engagements span EV design, vaccine development, lab services, clinical research, and infrastructure systems. -Expertise covers a wide spectrum: aerospace, defense, healthcare, manufacturing, software systems, environmental and civil engineering.

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