Quality Systems Specialist

Overview

In this role, you will lead the administration of the equipment management program for a specialized medical technology company. You will take full ownership of the equipment lifecycle, ensuring that every device across Research and Development, Manufacturing, and Field Service is properly identified, calibrated, and audit-ready at all times. This position places you at the intersection of quality compliance and operational efficiency, where you will manage vendor relationships and internal documentation to maintain business continuity. You will join the Quality Systems and Compliance team, a group known for its cross-functional reach and multifaceted responsibilities. Your work will directly support the integrity of the company's manufacturing and clinical operations by overseeing complex preventative maintenance schedules and resolving equipment-related discrepancies. As the company scales, you will also have the opportunity to streamline existing processes and implement innovative solutions for asset tracking and regulatory adherence.

Responsibilities

• Manage the end-to-end equipment lifecycle including intake, identification assignment, and eventual retirement of assets.
• Schedule and coordinate all calibration and preventative maintenance activities with internal owners and external vendors.
• Track equipment events such as out-of-tolerance conditions and unplanned maintenance to ensure timely resolution and documentation.
• Maintain the equipment inventory for Field Service Engineers by coordinating replacement shipments and tracking returns.
• Review and archive all calibration and qualification records to ensure accuracy and compliance with regulatory standards.
• Conduct quarterly equipment walkthroughs to identify and correct labeling or documentation gaps across various departments.
• Support internal and external audits by providing necessary equipment documentation and participating in regulatory reviews.

Qualifications

• You must hold a Bachelor’s degree and have at least 2 years of relevant professional experience.
• You need a strong working knowledge of ISO 13485, 21 CFR 820, and 21 CFR Part 11 standards for medical devices.
• You must demonstrate proficiency in Microsoft Office tools, particularly Excel and Word, for data tracking and reporting.
• You should have experience managing equipment records or asset databases in a regulated environment.
• You need excellent communication skills to coordinate activities between equipment owners and third-party calibration providers.
• You must be detail-oriented with the ability to manage complex schedules for a large, multi-department inventory.

Nice to have

• Experience specifically using the xTrak asset management system or an equivalent database is highly preferred.
• An ASQ certification or Certified Quality Engineer (CQE) credential is recommended to demonstrate advanced expertise.
• Familiarity with data visualization tools like Power BI or project management software like Smartsheet is beneficial.

Work environment

• This is an on-site position based at the company headquarters in Aliso Viejo, California.
• You will work in a dynamic, cross-functional environment interacting with R&D, Manufacturing, and Facilities teams.
• The role requires physical participation in facility walkthroughs to verify equipment status and labeling.
• You will follow a standard 40-hour work week within a professional medical device manufacturing setting.

Benefits & growth

• The salary for this position is established within an estimated range of $85,000 to $100,000 per year.
• You will have opportunities to lead process improvement initiatives as the company expands its quality systems.
• The role offers exposure to diverse areas of medical device operations, including quality assurance and field service logistics.
• You will participate in a structured training plan and receive guidance on global anti-corruption and business ethics policies.