What are the responsibilities and job description for the Quality Management Systems Administrator position at Treace?
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.
