Status: Full Time – Non-exempt

Reports To: QA/QC Manager

A.Purpose and Scope of Position

This position is responsible for technical aspects of quality including material and product inspection and testing, involvement in product development, and process validation. In addition to these duties, this position creates and reviews documents as well as reports and participates in wide variety of quality tasks in order to maintain a Quality System that meets the standards of FDA CFR Title 21 parts 820 and 1271, AATB, and ISO 13485. This position interacts with employees throughout the company, with other Xtant Medical Divisions, and with a variety of external contacts.

B.Organizational Relationship

This position reports to the QA/QC Manager and is responsible for communicating effectively with other individuals within all departments. This position may
provide additional support to other supervisors, managers, or departments as requested.

C.Duties and Responsibilities

1. Specific Job Duties/Responsibilities

• Develop and maintain an understanding of the requirements of the Food and Drug Administration (FDA) Code of Federal Regulations Title 21, Parts 820 and 1271;

American Association of Tissue Banks (AATB); International Organization of Standardization (ISO) 13485; European Medical Device Directives (MDD); and Canadian Medical Device Regulations as applicable and adhere to standards and regulations to help the company lead the Medical Device and Biologics industries in quality practice.

• Adhere to Xtant Medical Standard Operating Procedures (SOPs) and safety protocols, FDA Regulations for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) and Devices; operate in compliance with FDA, AATB, ISO, and Occupational Safety and Health Administration (OSHA) Standards.

• 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.

• Support Xtant Medical’s mission to design, manufacture, and distribute innovative, safe, reliable, and cost-effective solutions for the medical needs of patients.

• Perform all duties according to SOPs and Good Documentation Practices (GDP) and follow appropriate safety precautions and measures.

• Represent the company in a professional manner to the public, customers, and vendors, and maintain trusting relationships with physician partners, customers, and fellow employees.

• Review incoming Device History Records for accuracy, completeness, and conformance in accordance with procedures, and shipping and production schedules.

• Ensure product specifications are met on incoming documentation.

• Perform non-conforming material processes per internal procedures.

• Perform labeling inspection and sampling of products as required by documented procedures.

• Communicate effectively with QC, Fulfillment, and Supply Chain personnel to determine priorities.

• Complete Traceability Documentation associated with ISO and FDA regulations.

• Ability to manage multiple tasks, effectively utilize PC applications and have a sense of urgency in a fast-paced environment.

• Communicate effectively with suppliers to resolve incoming documentation issues.

• Participate in other duties and activities as assigned by management, such as data collection and analysis.

2. Financial Responsibilities

• Maintain strict confidentiality of all company, customer, and donor information.

• Submit timely expense reports and abide by the Expense Reimbursement Policy.

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 supervise others.

5. Document Control and Record Control

• May assist in the development and maintenance of Document Control and Record Control systems that meet FDA, AATB, and ISO standards and regulations.

• Assist in the completion and retention of documentation pertaining to SOPs. Understand the importance of completing and maintaining documents and records without any errors.

• Legibly and accurately complete all documentation associated with assigned duties in accordance with current GDP and review the information of others as required.

• Write and revise a variety of technical documents including SOPs (Standard Operating Procedures), quality standards and specifications, training documents, and inspection and testing protocols as needed and assigned.

• Participate in the completion of Device History Records (DHR).

• Participate in changes to documents and to products and processes.

• Maintain information in physical and electronic files as required.

• Respond to and prioritize requests for Document Numbers, Part Numbers, etc. and maintain adequate records and updating, In-Use Logs as necessary.

6. Other duties as assigned

7. Performance of Duties

• Complete required training prior to performing tasks, including initial orientation and environmental health and safety training. 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, consumers, and end users.

• Maintain a clean and safe working environment at all times.

• Must maintain confidentiality of donor and recipient information.

• Must complete multiple projects at the same time, often independently under moderate supervision.

D. Job Requirements

1. Education/Credentials Experience & Training

• AA degree is preferred one (1) year minimum experience in QA functions and/or manufacturing, preferably in an FDA regulated industry, or equivalent experience

is required.

• ERP and automated document control experience is desired.

2. Technical Requirements/Skills

• Knowledge of FDA, ISO, and AATB quality system requirements as applicable.

• Must have strong written and verbal communication skills and demonstrated customer interaction skills.

• Ability to read engineering drawings as well as interpret and apply GD&T Tolerancing to raw data results is required.

• Knowledge of ISO 13485 Medical Devices Quality Management System and FDA 21 CFR Part 820 Quality System Regulation is highly desirable.

• Ability to write, review, and edit technical reports and SOPs.

• Ability to train, cross-train, direct, and mentor others.

• Ability to multitask.

• Interpret complex data and make sound judgments based on those interpretations.

• Must possess excellent organizational skills and strong attention to detail.

• Proficient computer skills required such as basic knowledge of MS Word, Excel, Power Point, 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 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 moderate 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.

• Must be able to communicate with suppliers and other regulatory agencies as necessary.

• Ability to maintain good working relationships with all co-workers and the general 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.

5. Working Conditions

• Working conditions are normal for an office environment. Standard office hours are Monday – Friday; 8:00 am – 5:00 pm.

• Working conditions include normal office environment, laboratory setting, environmentally controlled area (ECA), cleanrooms, and other sterile environments. Work may require occasional weekend/evening work and 4 hours of standing.

• Duties may include contact with human tissue, blood, bone, and fluids.

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, MSDS/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.

• Must be able to lift 60 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 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.