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Job Title: QMS Complaints AssociateJob Description

Join a dynamic team dedicated to improving patient lives through the supply of life-changing medical devices. As a QMS Complaints Associate, you will play a crucial role in analyzing customer complaints and ensuring compliance with regulatory standards. Your work will directly support the growth and quality management systems of our organization.

Responsibilities

+ Analyze and process customer complaints.

+ Initiate and complete Medical Device Reporting (MDRs) for timely submission to the FDA and other regulatory bodies.

+ Assist with product recalls and advisory notices.

+ Track and communicate adverse event data, performing trending analysis.

+ Maintain current knowledge of FDA and international regulations, guidance, and standards applicable to company products.

+ Communicate with outside parties in a professional and customer-focused manner.

+ Support internal and external audits.

+ Assist with controlled documentation relating to complaint processes.

+ Perform other related duties as assigned.

+ Support the RA/QMS department in implementing and maintaining quality management system processes.

+ Handle complaint processing, including administrative intake, follow-up, reporting, and SAP processing.

+ Manage document processing and tracking of controlled documents.

+ Assist with calibration procedures and quality data collection.

+ Coordinate in creating and maintaining material master data.

+ Communicate with sales representatives regarding customer/provider complaints.

Essential Skills

+ Experience in Medical Device Manufacturing QMS with MDR/Complaint investigation experience.

+ 4 years of administrative experience and a degree, or 5+ years total experience in a professional, data-driven administrative role.

+ Proficient user of Microsoft Office applications, with intermediate knowledge of MS Excel.

+ Proficient with Microsoft Outlook.

+ Excel skills including Pivot Tables, Sorting Data, Searching Data, and Organizing specific data.

Additional Skills & Qualifications

+ SAP experience preferred.

+ MDR or Complaint investigating experience in Medical Device is highly desirable.

+ ISO experience, exposure, or internship is highly desirable.

Work Environment

This role offers a flexible work-from-home arrangement with some in-office presence as requested. You will work in a cubicle-style office environment alongside the regulatory and QA team.

Job Type & Location

This is a Permanent position based out of JACKSONVILLE, Florida.

Pay and Benefits

The pay range for this position is $48000.00 - $50000.00/yr.

401kMedicalDentalProfit sharinghybrid working structure

Workplace Type

This is a fully remote position.

Application Deadline

This position is anticipated to close on Nov 8, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email [email protected] (%[email protected]) for other accommodation options.