RA/QMS Compliance Training Associate

*This role is remote, but applicants must be located within 50 miles of KLS Martin's Jacksonville location*

Who We Are

At KLS Martin, we offer a unique opportunity to contribute to the success of a dynamic and thriving company whose products are used daily across the world to help surgical patients.

The KLS Martin Group is a worldwide leader in creating surgical solutions for the craniomaxillofacial and cardiothoracic fields. Surgical innovation is our passion, and we are constantly working with surgeons to improve surgical care for their patients. Our product portfolio includes titanium and resorbable implants for reconstruction, innovative distraction devices to stimulate bone lengthening, over 4,000 surgical instruments, and other surgical products designed specifically for CMF and cardiothoracic surgeons.

KLS Martin is an innovative leader in the treatment of CMF deformities and trauma cases. We use Individual Patient Solutions (IPS) by using our proprietary IPS products where CT scans are used to custom design implants that are created specifically for that individual patient. This technology allows our surgeons to provide the best-in-class treatment for their patients.

KLS Martin Guiding Principles

• Established, Privately Held Business Group - Responsive to customers, not shareholders. KLS Martin has manufactured medical products since 1896, and we have sold our products in the United States under the KLS name since 1993. We have always been, and always will be, privately owned.
• Patient Focus - We design products with the patient in mind - CMF, Thoracic & Hand
• Product to Table - Integrated planning, design, manufacturing and distribution process
• Educational Partner - Our primary focus for support is on education
• Inventory Alliance - Inventory management is critical to patient treatment/outcome
• Surgical Innovation is Our Passion - More than just a tagline

What We Offer

• We provide full-time employees with a competitive benefits package, including paid parental leave
• In-house training and professional development opportunities
• A culture of creativity and innovation by drawing on diverse perspectives and ideas to drive surgical innovation

Job Summary

Provides compliance training support for KLS to ensure regulatory and quality requirements are met. Supports daily operations by assisting in course deployment, user management, system troubleshooting, and reporting. Exercises discretion and independent judgement related, but not limited to, adverse events, production operations, and the quality management system.

Essential Functions, Duties, and Responsibilities

• Assist in the management of training programs to ensure compliance with FDA Quality System Regulations, ISO 13482:2016, Health Canada and aligned internal requirements. Supporttraining needs to ensure established procedures and processes are maintained and improved.
• Collaborate with supervisors to manage Compliance Training Plans.
• Support LMS management; user accounts, training items/curricula, user groups, additional training requirements.
• Provide customer service to business regarding LMS functionality and access issues.
• Support planning and execution of internal quality compliance audits and supplier audits with respect to training reporting.
• Generate and distribute reports on training completion, user engagement, and QMS compliance.
• Maintains current knowledge of FDA and international regulations, guidance and standards applicable to role at KLS.
• Performs other related duties as assigned.

Educational and Experience Requirements

• 4 year Degree
• 1 to 2 years' work experience in a regulated industry preferred, or 4 years of experience in regulated industry
• Ability to develop and provide training on compliance policies, practices and reporting systems
• Experience and knowledge of ISO 13485:2016 and 21CFR820
• Proficient in reporting and data management of records
• Preferred experience administering LMS and creation of training content

Knowledge, Skills, and Abilities

• Maintains high integrity and confidentiality of company and department information
• Ability to work effectively with all levels of internal and external associates, customers, andcolleagues
• Excellent interpersonal skills with the ability to effectively communicate at all levels internally as well as externally
• Ability to follow through on issues, make informed decisions that comply with policies and procedures, complete tasks and problem solve
• Ability to work with minimal supervision
• Ability to manage multiple priorities
• High Attention to detail
• Ability to work both independently and within a team environment

Skill Requirements

• Typing/computer keyboard
• Utilize computer software (specified above)
• Retrieve and compile information
• Maintain records/logs
• Verify data and information
• Organize and prioritize information/tasks
• Verbal communication
• Written communication
• Research, analyze and interpret information
• Investigate, evaluate, recommend action

Physical Requirements

• Sitting for extended periods
• Extended periods viewing computer screen
• Walking
• Reading
• Speaking
• Hear/Listen
• Maintain regular, punctual attendance
• Writing

Hazards

• Normal office environment

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

KLS Martin is a drug free employer