Quality Systems Specialist at Infinium Medical Inc

Largo, Florida, United States -

Full Time

Start Date

Immediate

Expiry Date

29 Sep, 26

Salary

110000.0

Posted On

01 Jul, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

eQMS Administration, Document Control, Quality Assurance, Regulatory Compliance, ISO 13485, FDA 21 CFR Part 820, EU MDR 2017/745, CAPA, Change Control, Root Cause Analysis, Internal Auditing, Workflow Design, Product Testing, Validation, Greenlight Guru, SAP Business One

Industry

Medical Equipment Manufacturing

Description

Description Quality Systems Specialist Build. Improve. Lead. Location: Largo, Florida Department: Quality Assurance Reports To: Director of Quality Position Overview 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. Your Mission Your primary responsibility will be to own, maintain, optimize, and continually improve Infinium Medical's electronic Quality Management System. We are not simply looking for someone to administer software. We are looking for someone who can think strategically about how technology can improve compliance, automate workflows, simplify processes, improve visibility, and help the organization become more efficient. This position requires someone who enjoys learning new technology, understands workflow design, and continually looks for better ways to utilize our eQMS to support the business. As a growing medical device manufacturer, this role combines several complementary quality functions that naturally work together. Responsibilities vary throughout the year based on business priorities, audits, product development, manufacturing activities, and regulatory initiatives, providing a diverse and engaging work environment. If you enjoy solving problems, improving systems, leveraging technology, and taking ownership of meaningful work, you'll find tremendous opportunity here. What Success Looks Like During your first year, the successful candidate will: Become the primary administrator and subject matter expert for our electronic Quality Management System. Continue building and optimizing Greenlight Guru to support future organizational growth. Improve document workflows and training management through thoughtful system enhancements. Identify opportunities to automate manual quality processes and improve efficiency. Build strong working relationships across every department. Support successful internal, customer, and regulatory audits. Help strengthen our culture of quality and continuous improvement. Position the Quality Management System to scale alongside future company growth. Key Responsibilities Quality Systems Ownership 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. Quality Operations 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. Regulatory & Compliance 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. What Makes You Successful The ideal candidate: Thinks like a systems builder. Enjoys learning new technologies. Naturally looks for opportunities to improve processes. Is comfortable owning important projects with minimal supervision. Can balance strategic thinking with attention to detail. Builds strong relationships across departments. Understands that compliance and operational efficiency should work together - not compete. Takes pride in creating systems that help an organization grow. Why Join Infinium Medical? We're making a significant investment in our Quality Management System and are looking for someone who wants to help shape what comes next. This is an opportunity to become a key contributor within our Quality organization while working closely with leadership across Engineering, Manufacturing, Regulatory Affairs, and Operations. If you're looking for a position where you can simply maintain an existing system, this probably isn't the right fit. If you're excited by the opportunity to improve systems, influence how quality supports the business, and grow alongside a company that values innovation and continuous improvement, we'd love to hear from you. Compensation & Benefits Proposed Salary Range: $80,000–$110,000 annually (commensurate with experience) Comprehensive benefits package including: Health, Dental & Vision Insurance Health Savings Account (HSA) 401(k) with Company Match Paid Time Off & Paid Holidays Short-Term & Life Insurance 529 College Savings Plan Performance Bonus Opportunities Professional Development Support Collaborative, team-oriented environment Long-term career growth opportunities Requirements Qualifications Required 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. Preferred Greenlight Guru implementation or expansion experience. Internal Auditor certification. SAP Business One experience. Product testing or validation experience. Experience supporting global regulatory compliance.

Responsibilities

The role focuses on owning and optimizing the electronic Quality Management System (eQMS) to improve compliance and operational efficiency. Additionally, the specialist manages controlled documents, supports regulatory audits, and assists with CAPA and nonconforming material activities.