QMS Coordinator

Job Title: QMS Coordinator

The QMS Coordinator plays a key role in supporting regulatory and quality activities with a strong focus on complaint processing and Quality Management System (QMS) administration. This position coordinates the full lifecycle of product complaints, maintains accurate quality records, supports document control and calibration processes, and contributes to ongoing quality and regulatory initiatives within the medical device environment.

Responsibilities

• Coordinate and administer regulatory and quality tasks with a primary focus on complaint processing and QMS support.
• Receive, log, and process customer and provider complaints in accordance with internal procedures and applicable regulatory requirements.
• Coordinate complaint investigations, track progress, and ensure timely and compliant closure of complaint files.
• Support the intake and administrative handling of complaints, gathering relevant information from internal and external sources.
• Report and process complaints in SAP and other designated systems, ensuring data accuracy and completeness.
• Maintain accurate, complete, and compliant complaint records throughout the entire complaint lifecycle.
• Update tracking systems and maintain documentation to ensure audit-ready complaint files at all times.
• Coordinate product returns related to complaints with internal teams and external partners, tracking and documenting product movement as part of the complaint process.
• Serve as a backup for Document Management, including processing, tracking, and maintaining controlled documents.
• Review and assist with drafting and updating controlled document procedures related to complaint handling and QMS activities.
• Collect, compile, and analyze complaint data to prepare summaries and reports for internal quality reviews and management reporting.
• Assist as a backup coordinator with calibration-related procedures to support equipment and process compliance.
• Assist in creating and maintaining material master data in applicable systems, ensuring data integrity and accuracy.
• Support the collection, entry, and analysis of quality data to assist regulatory and quality functions and broader QMS initiatives.
• Maintain data integrity within the Quality Management System and prepare summaries or reports as needed.
• Support audit and inspection activities by preparing complaint files and documentation for internal audits and external regulatory inspections.
• Collaborate with cross-functional teams, including Quality, Regulatory, Customer Service, Sales, and Operations, to collect information and resolve complaint-related issues.
• Communicate with sales representatives regarding customer and provider complaints and follow up as needed.
• Contribute to ongoing quality management systems and initiatives aimed at continuous improvement and regulatory compliance.

Essential Skills

• 2-year degree plus 2 years of administrative experience, or 4 years of administrative experience in lieu of a degree.
• Proficient user of Microsoft Office applications, including Word, Excel, Outlook, and PowerPoint.
• Intermediate knowledge of Microsoft Excel, including use of pivot tables, sorting data, searching data, organizing specific data, and creating or amending spreadsheets based on requests from product or sales representatives.
• Strong organizational skills with the ability to manage multiple tasks, track complaint status, and maintain accurate records.
• High attention to detail and commitment to maintaining data integrity within quality and regulatory systems.
• Ability to follow established procedures and regulatory guidelines related to complaint handling and quality documentation.
• Effective written and verbal communication skills for interacting with internal teams and sales representatives regarding complaints and quality issues.

Additional Skills & Qualifications

• SAP experience is preferred, particularly for complaint and material master data processing.
• Experience with MDR (Medical Device Reporting) or complaint investigation in the medical device industry is highly desirable.
• Exposure to or experience with ISO standards, including internships or project work, is highly desirable.
• Familiarity with medical devices, including surgical implants, is an advantage.
• Background or experience in quality assurance within a regulated industry is beneficial.
• Understanding of FDA-related complaint and reporting expectations for medical devices is a plus.
• Interest in supporting life-changing medical devices that positively impact patients in need.

Work Environment

This role operates within a medical device quality and regulatory setting that combines remote work with some in-office presence as requested. When on-site, you work in a cubicle-style office environment alongside regulatory and quality assurance team members, using standard office technology, Microsoft Office applications, and systems such as SAP to manage complaints, documentation, and quality data. The position offers the opportunity to contribute to the growth of an organization that supplies life-changing medical devices, in a collaborative, process-driven environment that emphasizes compliance, accuracy, and continuous improvement.

This is a Permanent position based out of JACKSONVILLE, FL.

The pay range for this position is $44000.00 - $46000.00/yr.

full benefits, 401k, medical, dental

This is a hybrid position in JACKSONVILLE,FL.

This position is anticipated to close on Apr 24, 2026.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I is embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

Actalent is an equal opportunity employer.

About Actalent

Actalent is a global leader in engineering and sciences services. For more than 40 years, we’ve helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APAC—with four delivery centers in India led by 1,000 extraordinary employees who connect their passion with purpose every day.

Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at actalentservices.com.

Salary : $44,000 - $46,000