Quality Systems Specialist

Infinium Medical Inc•Largo, FL

1d•$80,000 - $110,000•Onsite

About The Position

We are looking beyond simply filling a position - we are looking to invest in someone who can become a long-term contributor to the future of Infinium Medical's Quality organization. As we continue to grow, our Quality Management System must evolve with us. We are seeking a Quality Systems professional who is passionate about building systems, leveraging technology, improving processes, and advancing our Quality Management System to support the next phase of the company's growth. This role is centered around ownership of our electronic Quality Management System (eQMS). While the position also supports document control, quality assurance, regulatory compliance, product testing, audits, and continuous improvement activities, the primary mission is to continually strengthen and expand our Quality Management System so it supports both regulatory compliance and operational excellence. The successful candidate will partner closely with Manufacturing, Regulatory Affairs, Operations, Customer Service, and executive leadership to ensure our quality systems remain efficient, scalable, and aligned with the future growth of the organization. This is an opportunity for someone who wants to build a career - not simply perform a job. As Infinium Medical grows, we expect this position to grow with it, providing increasing responsibility, professional development, and the opportunity to advance into quality leadership.

Requirements

Associate's or Bachelor's degree in Quality, IT, Engineering, Life Sciences, Manufacturing, or a related field, or an equivalent combination of education and experience.
3–5+ years of experience in Quality Systems, Quality Assurance, or Document Control within the medical device industry.
Experience administering and optimizing an electronic Quality Management System (Greenlight Guru strongly preferred).
Experience working within ISO 13485 certified and FDA regulated environments.
Working knowledge of FDA Quality System Regulations (21 CFR Part 820/QMSR).
Working knowledge of European Union Medical Device Regulation (EU MDR 2017/745).
Experience with CAPA, Change Control, Complaints, NCRs, Internal Audits, and Document Control.
Strong technical aptitude and the ability to understand software workflows - not simply use software.
Excellent analytical, organizational, and communication skills.
Experience coordinating with external auditors, consultants, and regulatory agencies.

Nice To Haves

Greenlight Guru implementation or expansion experience.
Internal Auditor certification.
SAP Business One experience.
Product testing or validation experience.
Experience supporting global regulatory compliance.

Responsibilities

Serve as the primary administrator and subject matter expert for the company's electronic Quality Management System (Greenlight Guru preferred).
Maintain, configure, optimize, and expand the eQMS to support evolving business and regulatory requirements.
Evaluate current workflows and identify opportunities to automate and streamline quality processes.
Configure forms, workflows, dashboards, reports, notifications, and system functionality.
Coordinate implementation of new eQMS functionality, software updates, and validation activities, as appropriate.
Develop user guidance and train employees on effective utilization of the eQMS.
Maintain quality records, training records, document workflows, and Management Review metrics.
Identify opportunities to improve quality system processes, documentation workflows, and operational efficiency.
Manage controlled documents through creation, revision, approval, release, distribution, and archival.
Maintain SOPs, Work Instructions, Forms, Specifications, Device Master Records (DMRs), Device History Records (DHRs), Technical Documentation/Technical Files, and Quality Records.
Review quality documentation for completeness prior to product release.
Support product testing, verification, validation, inspection, and equipment calibration activities as business needs require.
Document test results and maintain associated quality records.
Assist with complaint investigations, CAPA, change control, nonconforming material (NCR) activities, and root cause investigations.
Support compliance with ISO 13485, FDA Quality System Regulations (21 CFR Part 820/QMSR), and European Union Medical Device Regulation (EU MDR 2017/745), as applicable.
Prepare documentation for internal, customer, external, and regulatory audits.
Participate in internal audit activities and follow-up actions.
Coordinate with external auditors, consultants, and regulatory partners as needed.
Support global regulatory compliance initiatives.