Status: Part Time – Non-exempt

Reports To: QA/QC Manager

A. Purpose and Scope of Position

This position will contribute to the maintenance and management of an effective Quality Management System (QMS) within the QA/RA department. This position ensures that Xtant complies with and meets the regulatory requirements and industry standards of FDA, AATB, ISO and other regulatory agencies as applicable.

B. Organizational Relationship

This position reports directly to the QA/QC Manager. This position will interact with employees in the Department and will frequently interact with other Department Managers, Supervisors, and employees.

C. Duties and Responsibilities

• 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
  • Develop and maintain an understanding of Xtant products and general biological and chemical systems utilized within the Company. Understand 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’s Standard Operating Procedures (SOPs) and safety protocols
  • Support Xtant’s mission to design, manufacture, and distribute innovative, safe, reliable, and cost-effective solutions for the medical needs of patients
  • 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, customers, and fellow employees
  • Communicate effectively with suppliers to resolve incoming documentation and quality issues
  • Work with all departments and divisions within Xtant to ensure adherence to Xtant’s Quality Management System
  • Support manufacturing activities from a Quality perspective in accordance with the requirements of 21 CFR 820, 21 CFR 1271, ISO 13485, and MDSAP (per jurisdictional areas)
  • Review Device History/Batch Records for accuracy, completeness and conformance with documented specifications and procedures. Perform in-process and final review and release of Processing and/or hardware batch records
  • Perform label review/approval
  • Perform inspection of WIP product
  • Perform receiving inspection and testing, as required, on materials and outsourced finished goods using applicable specifications, procedures, and related equipment (Sartorious Balance, Smartscope, comparator, calipers, micrometers, etc.)
  • Perform routine review of records including, but not limited to:
    • Lyophilization logs
    • Equipment records (calibration certificates, return to service inspections, equipment qualification, etc.)
    • Receiving inspection
    • Facility cleaning logs
    • Returns processing
    • Environmental monitoring
  • Participate in QMS Activities including, but not limited to:
    • Error and Nonconformance Management process
    • Corrective Action and Preventive Action (CAPA) process
    • Quality Planning process
    • Planned Deviation process
    • Supplier Qualification process
    • Change Control process
    • Engineering Studies
    • Validation activities
    • Document Control
  • Participate in and demonstrate a general understanding of the sterilization validation process and applicable requirements
  • Participate in Dose Audit/Routine Bioburden Monitoring including working with outsourced laboratories for quotes, sample requests, collection, sample submission and result reviews and trending
  • Participate in routine product testing: (e.g., Osteoinductivity, Endotoxin, Residual Calcium and Residual Moisture Testing) including sample collection, submission, results analysis/review, and trending
  • Participate in product or process development/improvement initiatives
  • Assist Department in conducting investigations, root cause analysis and development of corrective/preventive action plans
  • Assist Quality team with achieving organizational Quality objectives
  • Participate in internal audits and regulatory inspections as requested
  • Participate in training programs and ensure accuracy and timeliness in training records
  • New product code creation
  • Write and revise SOPs, Work Instructions, Forms, etc.
  • Participate in record control, scanning and archiving processes
  • Participate in risk management and design control as requested
  • This position may be required to train others
• Financial Responsibilities
  • Submit timely expense reports and abide by the Expense Reimbursement Policy
• Training
  • Participate in training plans and programs and complete in a timely manner within set deadlines
  • Complete required training, including initial orientation and environmental health and safety training, prior to attempting to perform a task
• Management
  • This position does not supervise others
• 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 Good Documentation Practices (GDP) and review the written documentation of others as required
  • Maintain information in physical and electronic files as required
• Other duties as assigned
• Performance of Duties
  • 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
  • Always maintain a clean and safe working environment and follow requirements to properly dispose of hazardous and non-hazardous waste according to OSHA regulations and Xtant SOPs
  • Must maintain confidentiality of donor and recipient information according to HIPAA

D. Job Requirements

• Education/Credentials Experience & Training
  • Bachelor’s degree from an accredited college or university is preferred
  • Minimum of two (2) years’ experience directly related to the duties and responsibilities specified in a regulated manufacturing environment. Previous medical device or HCT/P manufacturing is preferred
  • Professional certification (CQT-Certified Quality Technician, CQA-Certified Quality Auditor, CMDA-Certified Medical Device Auditor, CQPA-Certified Quality Process Analyst) is preferred, or must possess willingness to obtain
  • Certified Tissue Bank Specialist (CTBS) certification is preferred, or must possess willingness to obtain
  • ISO 13485 Lead Auditor Training is preferred, or must possess willingness
• Technical Requirements/Skills

• Knowledge of FDA, ISO, AATB, and all applicable standards and regulations
• Ability to demonstrate sound judgement and consult subject matter experts regarding quality decisions
• Ability to write, review, and edit technical reports and SOPs
• Must possess excellent communication skills (verbal, written, technical writing, in-person and virtual presentations to large and small groups)
• Must possess strong attention to detail
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
• Ability to adapt to quickly changing priorities and schedules
• Ability to apply effective time management strategies, to execute and prioritize multiple tasks under minimal supervision
• Proficiency with operation and use of all computer software necessary to execute duties including, but not limited to, ERP, MS Word, Excel, Power Point, Outlook, Teams
• Ability to assist in the development and presentation of educational programs and/or workshops
• Ability to investigate and analyze information to draw conclusions
• Must possess excellent organizational skills and strong attention to detail
• Track record of effective problem solving
• Proficiency with computer skills, such as basic knowledge of MS Word, Excel, PowerPoint, Outlook, and other software as necessary
• Ability to communicate effectively both orally and in writing and the ability to present effectively to small and large groups
• Ability to assist in the development and presentation of educational programs and/or workshops
• Ability to investigate and analyze information and to draw conclusions

3. Managerial Experience

• N/A

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

• 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 public and use good judgment in recognizing scope and authority
  • 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
  • Ability to travel as company representative

5. Working Conditions

• Working conditions are normal for an office environment. Standard office hours are Monday – Friday; 8:00 am – 5:00 pm
• Work may require long periods of sitting and working at a computer, and 4 hours of standing
• Working conditions may include a laboratory setting, environmentally controlled area (ECA), cleanrooms, and other sterile environments
• Work may require occasional weekend/evening work and travel
• Duties may include contact with human tissue, blood, bone, and fluids
• May work in conditions leading to minor personal discomfort such as in temperatures above or below personal comfort levels

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
• This position will sometimes be required to wear personal protective equipment (PPE), including laboratory coat, scrubs, and gloves, etc.
• Will require experience or training in the routine handling of chemicals and biohazards
• May require OSHA (bloodborne pathogen) training, SDS, and other safety training as applicable
• Hepatitis B vaccine is highly recommended and provided to employees who may have contact with human tissue at no cost to the employee. Any employee who declines a Hepatitis B vaccine will be required to sign a waiver

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.

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.