RA/QMS COMPLIANCE TRAINING ADMINISTRATOR

** This position requires you to reside within 50 miles of our Jacksonville, FL. offices due to occasional in-office responsibilities**

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

Management of processes and tasks to support compliance training for KLS to ensure meeting required regulatory and quality requirements. Work with cross-functional supervisors to ensuring training to QMS processes are identified and implemented in support of the Quality Management System. Exercises discretion and independent judgement related, but not limited to, adverse events, production operations, and the quality management system.

Essential Functions, Duties, and Responsibilities

* Develop and implement training programs to ensure compliance with FDA Quality System Regulations, ISO 13482:2016, Health Canada and aligned internal requirements.

* Identify training needs to ensure established procedures and processes are maintained and improved.

* Work to improve competencies with respect to the QMS.

* Support planning and execution of internal quality compliance audits and supplier audits with respect to training reporting.

* Develop, analyze and report quality metrics to drive improvement and efficiency for training processes related to QMS.

* Work within the LMS to ensure required training for QMS compliance is documented and reportable.

* Maintains current knowledge of FDA and international regulations, guidance and standards applicable to KLS.

* Performs other related duties as assigned

Educational and Experience Requirements

* 4-year degree plus 6 years work experience in a regulated industry, or8 years of experience in regulated industry

* Ability to develop and provide training on compliance policies, practices and reporting systems

* Proficient understanding and application of 13485 & competent knowledge of 21CFR820

* Proficient in Excel, ComplianceWire, SharePoint, reporting and data management of records.

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
• Ability to work both independently and within a team environment

Skill Requirements

• Typing/computer keyboard
• Utilize computer software (specified above)
• Retrieve and compile information
• Verify data and information
• Organize and prioritize information/tasks
• Verbal communication
• Written communication

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