Ventura Solutions

QA Recall Coordinator

Ventura Solutions  •  Mundelein, IL (Onsite)  •  5 hours ago
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Job Description

Our client is seeking a Quality Assurance Recall Coordinator to ensure external and internal customer requirements are met according to documented policies and procedures. This role supports Quality System activities, product recall operations, customer notifications, returned product processing, and documentation management to ensure compliance with internal requirements and applicable regulatory expectations. The primary purpose of this role is high-volume customer service, coordinating recall-related activities, customer communications, returned product handling, and record maintenance to support effective product recall execution. This position handles a high volume of inbound customer requests via phone and email.

Responsibilities

  • Assist in the establishment and maintenance of policies and procedures supporting the Quality Management System.
  • Assist with corrective actions resulting from process deviations, procedure deviations, complaints, regulatory audits, customer audits, and internal audits, under the direction of the Quality Supervisor or designee.
  • Prepare reports, tracking logs, status updates, and documentation for management and customers under supervision.
  • Handle the receipt, organization, verification, storage, processing, and return of products received from customers, including products associated with recalls and field actions.
  • Maintain designated returned product areas to ensure timely, accurate, and organized processing of returned product.
  • Assist with issuing return labels, return authorizations (RGAs), credits, replacement requests, and other documentation necessary to support recall resolution activities.
  • Print, prepare, and distribute customer notifications and related recall communications.
  • Maintain complete, accurate, and organized records to support quality, recall, and regulatory requirements.
  • Assist with reconciliation of recalled product returns and work with internal departments and external partners to resolve documentation discrepancies.
  • Communicate instructions related to the identification, segregation, and disposition of affected product to support product containment activities.
  • Assist with tracking key recall metrics, maintaining recall documentation, and supporting audit readiness activities.

Qualifications

  • High School Diploma or GED plus 2 years of relevant experience required; Associate's degree preferred.
  • 1–3 years of experience in inspection, quality assurance, medical device, pharmaceutical, healthcare, or regulatory work in a warehouse environment.
  • Strong attention to detail and organizational skills.
  • Ability to accurately maintain records, documentation, and tracking systems.
  • Ability to inspect, review, and resolve nonconforming issues with minimal supervision.
  • Strong verbal and written communication skills with customers, vendors, and internal departments.
  • Ability to follow written procedures, work instructions, and regulatory requirements.
  • Proficiency with Microsoft Office applications, including Outlook, Word, and Excel.
  • Ability to manage multiple priorities in a fast-paced, deadline-driven environment.
  • Strong interpersonal skills and ability to work collaboratively across departments.
  • Basic understanding of quality systems, complaint handling, product recalls, or regulatory requirements is a plus.
  • Experience supporting product recalls, customer notifications, returned product processing, or regulated documentation processes is a plus.
  • Zendesk experience is a plus.

Location

  • Mundelein, IL

Employee Type

  • W2
  • Contract for approximately 6 months, with potential for conversion to full-time based on performance and business needs

Compensation & Benefits for W2

  • Up to $23/hour, depending on experience
  • Medical and dental insurance
  • Paid vacation time
  • 401(k) after 90 days

About Ventura Solutions

Ventura Solutions is a reputable end-to-end medical device and combination product consulting, staffing, and training firm. With our deep industry expertise spanning medical devices and combination products, coupled with an outstanding talent pool, we stand out as the preferred option for a diverse array of projects. On the consulting side, we integrate seamlessly into your team and manage small to complex Statement of Work (SOW) projects. On the staffing side, we help source, screen, and on-board reputable employees to fill temporary, temp to permanent, and permanent job openings. We accelerate product development, keep products compliant, and help build great organizations. For more information, visit us at www.ventura-solutions.com.

Equal Opportunity Employer Minorities/Women/Veterans/Disabled

Ventura Solutions

About Ventura Solutions

Ventura Solutions provides End-to-End consulting, staffing, and training services for the Medical Device and Combination Products industry.

We provide consulting, staffing, and training solutions in the following areas:

-Design Controls

-Risk Management

-Verification & Validation

-Design and Development

-Project Management

-Quality

-Regulatory

-Human Factors

-DHF & Quality System Remediation

-Software as a Medical Device (SaMD)

-Statistics

-Clinical Affairs

-Market Access

-Funding

-NIH SBIR Grants

-Start-Ups

Ventura Solutions is your one-stop shop for getting your product to the market or keeping it compliant.

Detailed list of areas of expertise:

Medical Device & Combination Product Consulting

Design Controls, Risk Management, 21 CFR 820.30, ISO 13485, ISO 14971, Design and Development, Systems Engineering, Project Management, Quality Assurance, Human Factors, IEC 62366, Usability, Design Verification, Design Validation, Statistics, Design History File (DHF) Remediation, Software as a Medical Device (SaMD), Manufacturing, Change Control, Regulatory, FDA Q-Sub, Pre-Sub, Breakthrough Device Program (BDP), Investigational Device Exemption (IDE), 510(k), MDR

Medical Device Start-Up & Business Consulting

Co-Development Deals, Licensing Deals, Fundraising, Non-Dilutive Funding, NIH SBIR Funding, Mergers and Acquisitions (M&A), Commercialization, Valuations, Equity Distributions, Board of Directors, Leadership, Organizational Development, Building High Performing Teams, Concept Evaluation & Selection, FDA or EU Regulatory Strategy, Value Proposition

Staffing, Direct Placement, & Executive Recruitment

Medical Device Engineers, Risk Management Engineers, Systems Engineers, Human Factors Engineers, Design Verification & Validation Engineers; Test Method Development Engineers, Materials Engineers, Project Managers; Process Validation Engineers, Process Development Engineers, Quality Engineers, Design Assurance Engineers, Regulatory Affairs Specialists

Industry
Manufacturing & Production
Company Size
11-50 employees
Headquarters
Vernon Hills, IL
Year Founded
2016
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