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Quality Management Systems Administrator

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Company Description

Treace’s mission is to be the leader in the surgical treatment of bunions by establishing the Lapiplasty® System as the standard of care. We are committed to operating our business with the highest standards of ethical conduct. We intend to exceed our customers’ expectations through an innovation-driven, high-velocity approach to solving treatment and surgical problems. With our products and services, our mission is to assist foot and ankle surgeons in improving patient outcomes and reducing healthcare costs, while providing rewarding experiences and opportunities for our employees and stakeholders.

Job Description

POSITION SUMMARY:

The Quality Management System (QMS) administrator is primarily responsible for managing and optimizing our Product Lifecycle Management (PLM) system, Arena. The position will handle day-to-day system operations, provide user support, assist in the implementation of new modules, and drive continuous improvements in the PLM environment. Additionally, the QMS Administrator is responsible for responding to shifting priorities, managing changes, and overseeing configuration management and design control processes.

PRIMARY DUTIES AND RESPONSIBILITIES:

Implement, administer, and optimize the Arena PLM system, ensuring optimal performance, data integrity, and security.
Work closely with Engineering, Operations, Product Management, Customer Experience, and other teams to manage the day-to-day functional requirements of the PLM system, including process enforcement, administrative and technical support, and training.
Analyze current business practices and implement process improvements to enhance efficiency and effectiveness.
Modify Arena PLM configurations to meet evolving business processes, including the creation and management of configuration rules, BOM structure standards, and other system configurations.
Monitor, verify, and manage engineering change orders (ECOs), MCOs, deviations, and purge notifications in Arena.
Assist with the creation and management of Bill of Materials (BOMs), part numbers, and associated documentation, ensuring accuracy and compliance with regulatory requirements.
Collaborate with suppliers to obtain component specifications.
Provide training and technical support to internal and external users, enforcing system policies and best practices.
Develop and maintain system documentation, support projects and actions initiated in the Continuous Improvement program.
Participates in quality system audits (FDA, ISO, Internal, etc.) project Kaizens, and Rapid Improvement Events

Qualifications

EDUCATION & EXPERIENCE:

HS Diploma with at least 2 + years of hands-on experience managing PLM systems, preferably with Arena, in manufacturing or high-tech environments
A Bachelor's Degree in Computer Sciences, Engineering or other related technical field is strongly preferred.
Experience with Solidworks/NetSuite integration is a plus. Experience with consumer products, design control, and regulatory submissions is highly desirable

Additional Information

All your information will be kept confidential according to EEO guidelines.

Treace's Privacy Policy

It is Treace’s policy not to discriminate against any applicant for employment, or any employee because of age, color, sex, disability, national origin, race, religion, veteran status or any other characteristic protected by applicable law. EEO/Disabled/Veterans Employer

Treace is a drug free employer.

Average salary estimate

$70000 / YEARLY (est.)

min

max

$60000K

$80000K

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What You Should Know About Quality Management Systems Administrator, Treace

Join Treace as a Quality Management Systems Administrator in beautiful Ponte Vedra, FL! We're on a mission to redefine surgical treatment for bunions with our innovative Lapiplasty® System. As a part of our dynamic team, you will be the driving force behind managing and optimizing our Product Lifecycle Management system, Arena. This isn't just any role; it's an opportunity to shape our processes, ensuring data integrity while collaborating with talented cross-functional teams in Engineering, Operations, and Product Management. You'll be involved in a variety of exciting tasks, from day-to-day system operations and troubleshooting to implementing new modules and driving continuous improvements. Your expertise will also extend to overseeing configuration management and ensuring compliance with manufacturing standards. You'll play a key role in streamlining our processes and elevating our efficiency as we push the boundaries of foot and ankle surgery. Whether it's managing engineering change orders or providing critical training and support, your contributions will directly impact our mission of exceeding customer expectations and enhancing patient outcomes. If you're passionate about quality management, have a flair for technology, and possess at least 2 years of experience, we can’t wait to see how you fit into our Treace family!

Frequently Asked Questions (FAQs) for Quality Management Systems Administrator Role at Treace

What are the main responsibilities of a Quality Management Systems Administrator at Treace?

As a Quality Management Systems Administrator at Treace, you will manage and optimize the Arena PLM system, oversee day-to-day operations, collaborate across various departments like Engineering and Operations, and implement process improvements. Your role will also involve configuring system settings, managing engineering change orders, providing user training, and maintaining documentation to ensure compliance with regulatory standards.