Job Description
Job Description
1 Position Title
Quality and Inventory Specialist
2 Department / Team
Quality department
3 Reports To
The role reports to the Quality Director (Australia)
4 Position Purpose / Objectives
The Quality and Stores Specialist is the US based quality and stores representative for Epiminder, with a primary focus on quality control, quality operations and stores and logistic activities at the US facility. The role is responsible for ensuring that medical devices and associated materials are received, inspected, released, quarantined, distributed, and returned in compliance with regulatory requirements and Epiminder procedures.
The role supports regulatory compliance by maintaining inspection readiness and ensuring that the US site operates in accordance with Epiminder’s Quality Management System (QMS) and applicable regulatory requirements.
5 Key Responsibilities
The Quality and Stores Specialist is responsible for performing day-to-day quality control activities, managing customer complaints and inventory systems, and overseeing processes for product handling, storage, and distribution at the Epiminder US facilities. The Quality and Stores Specialist is responsible for supporting of the QMS and manages all on-site stores and logistics operations.
6 Authorities / Decision Rights
- The Quality and Stores Specialist has authority for:
- Release or quarantine of incoming, returned, and finished goods in accordance with approved procedures and regulatory requirements.
- Review and approval of quality records related to receiving, inspection, verification, distribution, and returns.
- Escalation of quality events, nonconformances, and compliance risks.
- Training of US-based staff on procedures and work instructions.
7 Key Relationships / Interactions
The Quality and Stores Specialist will interact closely with other employees in the Quality department and the Regulatory Specialist.
8 Core Activities & Deliverables
Stores/Quality Control
- Manage product receiving, storage, handling, shipping, and distribution activities in compliance with FDA and QMS requirements.
- Manage customer orders, purchasing and inventory systems to ensure timely and accurate distribution of devices.
- Establish and maintain processes for shipping, distribution, kitting, relabelling, and repackaging of medical devices
- Perform goods inwards inspections, First-Off Approvals (FOA), and incoming material inspections in accordance with approved procedures.
- Assist with firmware upgrades and other field-related tasks as necessary to support product functionality.
- Oversee the validation processes for software tools and computer systems to ensure compliance and functionality.
Quality Events & Complaint Handling
- Supporting quality event management systems, including complaint handling, CAPA, NCR, and SCAR processes.
- Review and assess returned, quarantined, and non-conforming products to determine appropriate actions.
General
- Supporting all staff to comply with the quality processes.
- Participating in project work as determined by Management.
9 Required Competencies & Skills
- The position of Quality and Stores Specialist has following minimum competency requirements:
- Previous industry experience in a Quality or Stores and logistics role ideally in a medical device/pharmaceutical field.
- Knowledge of ISO 13485 and 21 CFR Part 820, with 2 or more years of experience in operating QMS facilities is desirable.
- Understanding of Global Medical Device Regulatory Systems.
- Demonstrated experience in quality control activities, including receiving inspections, FOA, product release, quarantine, and distribution.
- Strong attention to detail, ensuring accuracy in inspections, documentation, and regulatory compliance.
- Excellent written and Verbal communication skills with the ability to listen, articulate and advocate
- Technical system skills (e.g. MS office applications, databases, efficient online research)
- Manage multiple projects and deadlines
- Ability to identify compliance risks and escalate when necessary
- Demonstrate both creative and critical thinking skill
10 Work Environment
The role is full time Monday to Friday 9-5, and an on-site role based at Epiminder’s Irving, Texas office.
Company DescriptionEpilepsy is the third most common neurological disease affecting 3.4m people in the US. Epiminder is a transforming epilepsy care through the development and commercialization of an implantable Continuous EEG Monitor (iCEM) that provides an objective understanding of seizure burden to inform physician and patient.
Company Description
Epilepsy is the third most common neurological disease affecting 3.4m people in the US. Epiminder is a transforming epilepsy care through the development and commercialization of an implantable Continuous EEG Monitor (iCEM) that provides an objective understanding of seizure burden to inform physician and patient.