Bone Bank Allografts, a subsidiary of Globus Medical Inc., specializes in processing and distributing high-quality bone allografts for various medical procedures, including orthopedic, dental, and reconstructive surgeries. Our commitment to excellence, supported by Globus’ renowned engineering, drives our mission to advance patient care and medical innovation through precise and efficient allograft processing and distribution.

Position Summary:

The CAPA Coordinator will work with all departments to assist with compliance and continuous improvement activities. The primary function will be to issue Non-Conformances (NCR), Corrective and Preventative Actions (CAPA), Supplier Corrective Action Requests (SCAR), Deviations, Complaints and ensure complete investigations, proper evaluations and risk analysis, and effective corrective and preventive actions are implemented. The position responsibilities may include the following, and other duties and responsibilities may be assigned, as necessary:

Essential Functions:

• Coordinate all Non-conformance, SCAR, and Deviation investigation issuance, final review, and closure

• Manage the complaint process to ensure thorough evaluation, closure, proper corrective action, and prompt and effective customer communication

• Manage all CAPA investigations to ensure thorough evaluation, proper root cause analysis, and effective corrective and preventative action is taken as necessary

• Maintain an accurate CAPA system database

• Prepare reports, metrics, trends, and graphs

• Schedule monthly department CAPA status meetings

• Report department CAPA status updates to management

• Assist with change implementation to drive continuous improvement and efficiency across the organization

• Review processing records, test results, certificates, etc., as needed

• Adhere to the letter and spirit of the company Code of Conduct, the AdvaMed Code, MedTech Code, and all other company policies

• Ensure Compliance with applicable governmental laws, rules, and regulations, both in the United States and internationally, by completing introductory and annual training and maintaining knowledge of compliance as it applies to your role

• Represent the company in a professional manner and uphold the highest standards of ethical business practices and socially responsible conduct in all interactions with other employees, customers, suppliers, and other third parties of Globus

• Other duties and responsibilities as necessary

Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.

Qualifications:

• Bachelor’s degree preferred

• 2+ years of experience within the biotech/tissue banking industry required

• 3+ years of experience with complaint and CAPA processes, investigations, and documentation preferred

• Knowledge of GMP regulations

• Must be knowledgeable with Microsoft word, PowerPoint and Excel programs

• Maintain a high attention to detail and strong typing and writing skills

• Proficient analytical skills and problem-solving techniques

• Excellent verbal and written communication

• Ability to maintain a service-oriented approach toward internal and external customers

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee is occasionally required to sit; balance; reach above shoulder level; push/pull and stoop, kneel, crouch/crawl. The employee must occasionally lift 25 pounds and occasionally move and/or carry up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.

Our Values:

Our Life Moves Us philosophy is built on four values: Passionate About Innovation, Customer Focused, Teamwork, and Driven.

• Passionate about Innovation: Improving patient care by delivering advanced technology to our customers is at the core of what we do. We are passionate about our role in improving the lives of patients by continuously developing better solutions.

• Customer Focused: We listen to our customers’ needs and respond with a sense of urgency.

• Teamwork: Working together, anything is possible. We value every person on our team and treat each other with respect. We are accountable to one another and support each other. Together, we make each other stronger.

• Driven: We pursue our mission with energy and passion. We are nimble, results-oriented, and decisive. We overcome obstacles that arise in our quest to deliver solutions that will improve the lives of our customers and patients.

Equal Employment Opportunity:

Globus Medical is an equal opportunity employer. All applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, age, disability, marital status, pregnancy, national origin, or citizenship. We are committed to a diverse workforce. We value all employees’ talents and support an environment that is inclusive and respectful.

Other Duties:

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.