Complaints Specialist

SharkNinja

About The Position

SharkNinja is a global product design and technology company, with a diversified portfolio of 5-star rated lifestyle solutions that positively impact people’s lives in homes around the world. Powered by two trusted, global brands, Shark and Ninja, the company has a proven track record of bringing disruptive innovation to market, and developing one consumer product after another has allowed SharkNinja to enter multiple product categories, driving significant growth and market share gains. Headquartered in Needham, Massachusetts with more than 3,600+ associates, the company’s products are sold at key retailers, online and offline, and through distributors around the world. The Customer Complaints Specialist is responsible for coordinating the intake, documentation, and routing of customer complaints within the organization’s Quality Management System (QMS). This role ensures that all customer complaints and feedback are recorded accurately and processed in compliance with internal procedures, ISO 13485, and applicable regulatory requirements. This position is non-technical and is focused on administrative accuracy, process adherence, and regulatory documentation rather than product investigation.

Requirements

High school diploma or equivalent required; Associate’s or Bachelor’s degree in a health, life sciences, business, or quality-related field preferred.
1–3 years of experience in a quality, compliance, or customer service support role, preferably in a regulated industry (medical device, pharmaceutical, healthcare).
Experience working with electronic or paper-based QMS platforms (e.g., MasterControl, Veeva, Greenlight Guru, TrackWise, or equivalent).
Excellent attention to detail and organizational skills.
Strong verbal and written communication.
Proficiency in using document management systems, spreadsheets, and collaborative tools.
Ability to manage multiple tasks and meet deadlines with minimal supervision.
Comfortable working in a fast-paced, regulated environment with a focus on compliance and accuracy.

Nice To Haves

Familiarity with ISO 13485, FDA 21 CFR 820, and complaint handling best practices is highly desirable.

Responsibilities

Monitor designated sources (customer service portals, email, phone logs, online forms) for new complaints and product feedback.
Review submissions for completeness and follow up with internal stakeholders to collect any missing required information.
Accurately log complaints in the QMS, ensuring each entry meets procedural and regulatory standards.
Initiate and route complaint records to the appropriate stakeholders (e.g., quality, engineering, regulatory) for further action and investigation.
Monitor the status of open complaints and ensure timely progression through all required stages (e.g., intake, initial assessment, investigation, closure).
Ensure all complaint-related records, attachments, and decision rationales are properly documented and traceable.
Ensure complaints are processed in accordance with company procedures and applicable regulations.
Confirm required reviews, approvals, and effectiveness checks are completed prior to complaint closure.
Support internal audits and inspections by preparing complaint files and records as requested.
Identify complaints that may involve reportable events and escalate to the appropriate personnel for regulatory assessment.
Assist in maintaining documentation needed to support complaint reporting activities for regulatory authorities.
Generate routine and ad hoc complaint summary reports for management and quality teams.
Provide updates on complaint trends and open complaint status during team meetings or quality reviews.
Collaborate with customer service, Return logistics, and QA/RA teams to facilitate efficient complaint processing.