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Quality Engineer II

Company: Xtant Medical Holdings Inc
Location: Belgrade
Posted on: January 24, 2023

Job Description:

Status: Full Time, ExemptReports To: Senior Manager, Quality EngineeringA. Purpose and Scope of PositionThis position will develop new and existing processes to incorporate Quality, ensure Quality Assurance capabilities upon implementation, and maintain/improve processes post-implementation. This position will also ensure that Design Controls, including Risk Management, are adhered to throughout all development activities (new products, new processes, & process improvements). This position interacts with employees in Operations and may interact with other department managers, supervisors, and employees. This position ensures that Xtant complies with and meets the standards of the FDA, AATB, ISO 13485, and other regulatory agencies as necessary.B. Organizational Relationship This position reports to the Senior Manager, Quality Engineering and may provide additional support to other departments as requested.C. Duties and Responsibilities

  • Specific Job Duties/Responsibilities
  • Develop and maintain an understanding of the requirements of the Food and Drug Administration (FDA); American Association of Tissue Banks (AATB); International Organization of Standardization (ISO) 13485; Medical Device Single Audit Program (MDSAP); and other regulatory jurisdictions, as applicable, to help the company lead the Medical Device and Biologics industries in quality practice
  • Adhere to Xtant 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 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
  • 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)
  • Perform Design Control activities such as Risk Management, trace matrixes, Verification & Validation, providing Quality input for design specifications, developing workflows, writing work instructions and SOPs, gate reviews, etc.
  • Support existing product/process development by evaluating data from production, NCs/Complaints (with root cause investigation), and engineering studies. Drive for improvement by implementing meaningful process changes
  • Lead efforts to identify quality gaps in the design of manufacturing-related processes and systems. Implement process improvements where quality is inherent, relevant, and effective within the processes. Develop new workflows that ensure quality throughout by implementing QC metrics within processes that minimize/eliminate preventable failure modes
  • Participate as a team member on product and/or process development projects.
  • Identify areas of opportunity for continual improvement and lean manufacturing throughout the facility
  • Support the efforts of QA/RA Management to achieve departmental goals and quality objectives
  • Manage and maintain Xtant Medical's Design History Files & associated processes
  • Manage and maintain Xtant Medical's Risk Management Files & associated processes
  • Participate in the following QMS activities:
  • Nonconforming Product Management
  • Supplier Management
  • Corrective and Preventive Actions
  • Internal and External Audits
  • Sterilization Validation/Dose Audits
  • Other QMS activities such as batch record review and product inspection (as applicable)
  • Financial Responsibilities
    • Submit timely expense reports and abide by the Expense Reimbursement Policy
    • Maintain strict confidentiality of all company, customer and donor information
    • 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
      • Complete annual SOP review and OSHA safety training as applicable
      • Train and monitor the training of others in Department activities. May review and maintain employee training records
      • Management
        • This position does not supervise others
        • Work with and support the activities of the Director of Regulatory Affairs and Quality Assurance
        • Document Control and Record Control
          • Assist in the completion and retention of documentation pertaining to all Device History File (DHF) and Change Management records 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
          • Write and revise a variety of technical documents including protocols, work instructions, standard operating procedures, forms, specifications, and training documents
          • Maintain information in physical and electronic files as required
          • Train on and demonstrate proficiency in Xtant Medical's document control system
          • Other duties as assigned
          • 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 and follow requirements to properly dispose of hazardous and non-hazardous waste according to OSHA regulations and Xtant Medical SOPs
            • Must maintain confidentiality of donor and recipient information according to HIPAAD. Job Requirements
            • Education/Credentials Experience & Training
              • Minimum of a Bachelor's degree from an accredited college or university in Engineering or related technical field of study
              • Minimum of four (4) years' experience in a Quality role, preferably in the Medical Device, Biologics, and/or pharmaceutical industries
              • Minimum of one (1) year of experience leading and executing Medical Device Risk Management and Design Control processes
              • Quality certifications (e.g., CQT, CQPA), Lean manufacturing and/or Six Sigma certifications are preferred
              • Technical Requirements/Skills
                • Advanced knowledge of FDA, ISO, & AATB regulations and guidance (e.g., Design Controls, Risk Management, GxP)
                • Must possess excellent organizational skills and attention to detail, ability to effectively communicate, and a strong aptitude for problem solving
                • Technical writing proficiency for creating, reviewing, approving protocols/reports, work instructions, forms, and SOPs
                • Advanced knowledge and experience in biologics manufacturing or other relevant cleanroom/aseptic environments. Advanced knowledge of volume and routine-manufacturing operations
                • Proficient computer skills required such as basic knowledge of MS Word, Excel, PowerPoint, Outlook, and other software as necessary3. Managerial Experience
                  • N/A4. Special Requirements/Physical Capabilities or Abilities, other Additional Desirable Qualifications
                    • Must be able to work independently with minimal guidance. Must be a team-player, able to constructively engage with cross-functional associates. Able to effectively work with external vendors, partners, agencies etc. as necessary.
                    • Able to work in a standard office setting, use standard office equipment, and to attend on-site and off-site meetings. 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 and travel
                      • Work may require long periods of sitting, standing, and working at a computer
                      • Working conditions may include a laboratory setting, environmentally controlled area (ECA), cleanrooms, and other sterile environments
                      • Duties may include contact with human tissue, blood, bone, and fluids (Clinical Laboratory, Donor Services, Engineering, Processing, Packaging and Labeling, etc.). Working in PPE such as cleanroom suits, with face shields and masks as necessary
                      • 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
                        • 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 SponsorshipXtant 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.


Keywords: Xtant Medical Holdings Inc, Billings , Quality Engineer II, Engineering , Belgrade, Montana

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