Qualitative Analyst - Operations

Status: Full Time - Exempt

Reports To: Director, Operational Planning

A. Purpose and Scope of Position

This position is responsible for overseeing, monitoring, and reporting operations performance and financial information by preparing and analyzing financial plans, forecasts, reports and presenting findings, analyses, and recommendations to Operations management. This position will also oversee production planning and develop key performance indicators. This person does not typically supervise others and will support the activities of the Operations Planning department. This position interacts with employees in the department and may interact with other departments and employees as required.

B. Organizational Relationship

This position reports to the Director, Operational Planning and is responsible for communicating effectively with other individuals within the Operations Planning department, Customer Service, Purchasing, and executive-level staff.

C. Duties and Responsibilities

1. Specific Job Duties/Responsibilities
   • Develop and maintain an understanding of the requirements of the applicable standards and regulations including, but not limited to, 21 CFR 820, 21 CFR 1271, AATB, MDSAP (per jurisdictional requirements), and ISO 13485. Adhere to and promote compliance with the applicable standards and regulations throughout the company
   • Support Xtant Medical’s mission, values, and Quality Policy
   • Maintain a clean and safe working environment at all times and follow requirements to properly dispose of hazardous and non-hazardous waste according to OSHA regulations and Xtant Medical SOPs
   • Develop and maintain an understanding of the Xtant Medical products and general biological and chemical systems utilized within the Department. Know how the activities performed in the Department are controlled by and interact with the Quality System and how they affect the production of medical devices and tissues as applicable
   • Adhere to Xtant Medical Standard Operating Procedures (SOPs), Good Documentation Practices (GDP), and safety protocols
   • Complete annual SOP review and OSHA safety training as applicable
   • Represent the company in a professional manner to the public, customers, and vendors, and maintain trusting relationships with physician partners, and fellow employees
   • Monthly reporting and analysis of company performance from an operations and financial perspective for the executive/leadership team and the Board of Directors
   • Maintain collaborative files and reports for Vendors
   • Preparation and review of Quarterly Business Review (QBR) and Board of Directors reports and deliverables.
   • Assist in preparation of presentations for Board of Directors, Core Team, & Leadership Team meetings.
   • Calculate metrics for goals and objectives (KPIs) for monthly/quarterly/annual goals
   • Management and analysis of key drivers of unit cost, yield, etc. (i.e., actual results versus budget/forecast)
   • KPI calculation and measurement
   • Margin analysis on new products or processes
   • Vendor performance analysis
   • Extract product level forecasts provided by Marketing into SKU level forecasts for production
   • Provide COO and Director of Operational Planning financial analysis to drive decision making including project costing profitability, and return on investment analysis
   • Work closely with the Director of Operational Planning and the Finance team to continuously improve our processes and procedures in the operations arena
   • Support New Product Development (NPD) by creating models for profitability analysis during feasibility phase
   • Become proficient in the use of the companies’ budgeting, forecasting, scorecard and Netsuite
   • Learn and become proficient within the BI360 environment
   • Oversee BI360 revenue reporting and build out custom reports as needed
   • Analyze and assist with transaction level data cleanup and implement new reporting fields as necessary
   • Assist Sales and Marketing in defining slow moving inventory
   • Analyze sales and production volume and value by product, customer, region, etc.
   • Produce user detail and graphical reporting for viewing and interpreting data
   • Reconcile transactions by comparing and adjusting data
   • Provide other ad-hoc reports (BI & Excel) and financial models as required by Director of Finance and Director of Operational Planning
2. Financial Responsibilities
   • Submit timely expense reports and abide by the Expense Reimbursement Policy
   • Perform Cost of Goods Sold (COGS) analysis of current period and comparison to prior periods as requested
3. Training
   • Participate in training plans and programs and complete in a timely manner within set deadlines
   • Complete required training prior to attempting to perform a task
   • Maintain required training documentation
4. Management
   • This position does not typically supervise others
   • Work with and support the activities of other Finance personnel and other departments including but not limited to Sales, Customer Service, Purchasing, and Accounting as requested
5. Document Control and Record Control
   • Assist in the completion and retention of documentation pertaining to all SOPs as required
   • Legibly and accurately complete all documentation associated with assigned duties in accordance with GDP and review the written documentation of others as required
   • Maintain information in physical and electronic files as required
6. Other duties as assigned
7. Performance of Duties
   • Complete required training, including initial orientation and environmental health and safety training, prior to performing tasks. Keep training up to date
   • Perform all duties according to established procedures and follow appropriate safety precautions and measures
   • Conduct himself/herself in a professional and courteous manner in all aspects of interaction with fellow employees, surgeons, staff, and end users
   • Maintain a clean and safe working environment at all times
   • Must maintain confidentiality of donor and recipient information according to HIPAA

D. Job Requirements

1. Education/Credentials Experience & Training

• Bachelor’s degree in Computer Science or equivalent from an accredited college or university is required
• Knowledge of generally accepted database maintenance practices

1. Technical Requirements/Skills

• SQL and Power BI experience is preferred
• SuiteQL experience is preferred
  • Some knowledge of FDA, ISO, and AATB requirements as applicable
• Demonstrated ability to communicate effectively both orally and in writing
• Ability to multitask
• Must possess excellent organizational skills and strong attention to detail
• Advanced computer skills required such as basic knowledge of MS Word, Excel, Power Point, Outlook, Netsuite, and other finance software as necessary
• Demonstrated experience utilizing Microsoft Excel and Access to create databases and spreadsheets for reporting and analysis
• Ability to interpret complex data and make sound judgments based on those interpretations
• Ability to investigate and analyze information and to draw conclusions
• Prior experience with records maintenance and document control required

3. Managerial Experience

• N/A

4. Special Requirements/Physical Capabilities or Abilities, other Additional Desirable Qualifications

• Excellent project management skills are required
• Must be able to reason independently and work with minimal guidance
• Ability to interpret data and make sound judgments based on those interpretations
• Must deal effectively with a wide variety of personalities and situations requiring tact, judgment, and poise
• Must be able to adapt to quickly changing priorities and schedules
• Ability to maintain good working relationships with all co-workers and the general public and use good judgment in recognizing scope and authority
• Must be able to communicate well and train others in complex and detailed financial concepts
• Must possess mobility to work in a standard office setting and to use standard office equipment and to attend meetings at various sites within and away from the office

5. Working Conditions

• Working conditions are normal for an office environment. Standard office hours are Monday – Friday; 8:00 am – 5:00 pm
• Work will require occasional weekend/evening work
• Work may require long periods of sitting, standing, and working at a computer

6. Health and Safety

• Must adhere to all health and safety requirements specified when entering laboratory and device manufacturing areas and in the handling of company products
• May require OSHA (bloodborne pathogen) training, SDS, and other safety training as applicable
• Must be able to lift 20 lbs.

Note: This Job Description is not designed to include a detailed listing of the activities, duties or responsibilities that may be required of the employee. This job description does not constitute an employment contract, implied or otherwise, and is subject to change by the employer as the needs of the employer and requirements of the job change.

This position does not offer current or future H-1B visa sponsorship.

Xtant Medical provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.