Document Control Specialist

Quality Documentation Manager

At Globus Medical, we move with a sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our team is inspired by the needs of these patients, and the surgeons and healthcare providers who treat them. We embrace a culture of exceptional response by partnering with researchers and educators to transform clinical insights into tangible solutions. Our solutions improve the techniques and outcomes of surgery so patients can resume their lives as quickly as possible.

Position Summary:

The primary function will be to manage and organize all quality documentation that is required by Globus Medical, Inc. and other regulatory agencies. This will include issuing, maintaining, controlling, and auditing documentation that is required for quality and cGMP compliance.

Essential Functions:

• Issues Quality System documents and coordinate the training process
• Issues device master record documents (manufacturing process specifications, inspection plans, routers, etc.) and other technical documents during the development, release, and maintenance phases of product realization
• Processes Document Change Orders (DCOs) to implement all controlled documentation and maintain the distribution of controlled copy documents
• Organizes and communicates status of work to management and other personnel as required and keeps them informed of objectives and progress
• Ensures documentation is complete, properly formatted and meets corporate standards
• Assists in assigning and tracking new part numbers through the development cycle
• Performs database searches, data analysis, and reporting to assist design engineers on product development
• Uses multiple manufacturing business systems, spreadsheets, graphs, word processors and product information management systems in order to facilitate document release, change, and data storage & retrieval processes
• Assists in conducting various training classes relating to documentation practices that pertain to Quality on an as-needed basis
• Oversees new item creations as well as set up within the system
• Creates and updates all BOMs and Routes
• Monitors all transactions within AX
• Troubleshoots and fixing any and all AX issues that arise, including improvements and functional testing
• Updates and maintains Net Dimensions training system
• Participates in continuous improvement activities and implements changes for improvement
• Keeps supervisor informed of work-related activities and issues related to agreed-upon goals and objectives
• Maintains cooperative and friendly attitude with coworkers
• Adheres to all company policies, procedures and housekeeping standards
• Adheres to the letter and spirit of the company Code of Conduct, the AdvaMed Code, MedTech Code, and all other company policies
• Ensures 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
• Represents the company in a professional manner and upholds the highest standards of ethical business practices and socially responsible conduct in all interactions with other employees, customers, suppliers, and other third parties

Qualifications:

• High school diploma or higher with minimum of 2 years progressive work experience, preferably in the medical device industry or other regulated industry
• Ability to review documentation for accuracy, perform data entry, scan and file documents
• Must be knowledgeable with Microsoft Word and Excel programs.
• Experience utilizing planning software
• Experience with training, developing and reviewing of planning software processes and procedures from a functional perspective
• Good organizational, typing, analytical, and critical thinking skills
• Good communication and writing skills

Physical Demands :

The physical demands listed here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

• Required to sit; climb or balance; and stoop, kneel, crouch or crawl
• Required to regularly lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds
• Required to possess specific visons abilities, including: close vision, distance vision, color vision, peripheral vision, depth perception and capacity 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 in 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.