Status: Full Time - Exempt
Reports To: Director of Quality
A. Purpose and Scope of Position
This person will not supervise others but will support the activities of QA/RA Management. This position interacts with employees in the Department and may interact with other Department Managers, Supervisors, and employees. This position helps ensure that Xtant Medical 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 Director of Quality, supports the activities of the QA/RA department, and may provide additional support to supervisors or other departments as requested.
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
- 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 Work with all departments and divisions within Xtant Medical to ensure understanding of and adherence to Xtant Medical’s Quality System
- Manage Supplier Qualification activities, including but not limited to, initial qualification, re-qualification, SCAR issuance, supplier qualification termination, etc.
- Plan and conduct regular audits with suppliers including onsite qualification of product and processes. Write audit reports to disclose findings, Present findings as needed. Maintain and update critical supplier audit system and schedule
- Support new supplier evaluation and qualification including inspection and first articles
- Measure, analyze, and improve supplier performance and reduce supplier nonconformances
- Work to resolve supplier technical issues in a timely manner to ensure continuity of supply
- Conduct receiving inspections, in-process inspections and finished device inspections
- Inspecting and monitoring receiving, in-process, and final product control results including collection and testing of representative samples
- Participate in and help lead successful external audits (FDA, ISO, etc.). Serve as a liaison between QA/RA Management and the auditor(s) during regulatory inspections
- Perform and participate in validations as needed
- Participate in design control as needed
- Help to accomplish quality objectives and develop quality standards
- Perform and manage Internal Audits as directed by QA/RA Management
- Participate in Complaint, Deviation, Nonconformance, and CAPA investigations as necessary
- Support the efforts of QA/RA Management to achieve departmental goals and quality objectives
- Financial Responsibilities
- Maintain strict confidentiality of all company, customer, and donor information
- Submit timely expense reports and abide by the Expense Reimbursement Policy
- Training
- Complete required training prior to performing tasks, including initial orientation and environmental health and safety training. Keep training up to date
- Perform annual training including but not limited to Annual SOP review, Annual Bloodborne pathogen training, etc.
- Train and supervise 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 QA/RA Management
- Help direct the activities of Department employees to accomplish quality and company objectives
- Assist in the hiring of skilled, responsible, and ethical individuals for the Department as necessary
- 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 information of others as required
- Write and revise a variety of technical documents including contracts, non-disclosure agreements, SOPs, and training documents as needed and assigned
- 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
- Perform all duties according to established procedures and follow appropriate safety precautions and measures
- Represent the company and conduct himself/herself in a professional and courteous manner in all aspects of interaction with the public, customers, vendors, 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
- Education/Credentials Experience & Training
- Bachelor's degree in biology-related, engineering or an equivalent course of study is required
- Five plus (5+) years’ experience in medical device, biologics, orthopedic or health industry quality assurance is preferred
- Corrective/preventive action, root cause analysis, effectiveness check, statistical application experience and training is required
- ISO 13485 Lead Auditor Certificate is preferred
- ASQ Certified Quality Auditor Certificate is preferred
- Six-sigma black-belt certification is preferred
- General knowledge of ISO 13485 and FDA Quality System Regulation guidelines required, advanced knowledge is preferred
- Regulatory and Quality auditing training and experience is required
- Experience and high level of proficiency in Microsoft Office Suite is required
- Experience with records maintenance and document control
- Experience in regulatory standards, regulatory inspection hosting, GLP, GMP and GDP
- High level of attention to detail and accuracy is required
- Strong organizational skills and ability to prioritize tasks is required
- Exceptional documentation and technical writing skills is required
- Excellent verbal and written English language skills is required
- Knowledge of FDA, ISO, and AATB requirements
- Ability to write, review, and edit technical reports and SOPs
- Must possess excellent organizational skills and strong attention to detail
- Ability to lead and influence others to drive change (cross-functionally and globally)
- Superior problem-solving skills, and the desire to help find solutions to internal and external customer needs
- Proficient computer skills required such as basic knowledge of MS Word, Excel, PowerPoint, Outlook, and other software as necessary
- Advanced 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
- Strong leadership and interpersonal skills and the ability to effectively communicate with a wide range of individuals in a diverse community
- Ability to investigate and analyze information and to draw conclusions
3. Managerial Experience
4. Special Requirements/Physical Capabilities or Abilities, other Additional Desirable Qualifications
- Must be able to reason independently and work with minimal supervision
- Ability to interpret data and make sound judgments based on those interpretations
- Ability to react quickly and adapt to changes in priorities, schedules, circumstances and direction is required
- Must deal effectively with a wide variety of personalities and situations requiring tact, judgment, and poise
- Ability to maintain good working relationships with all co-workers, the general public, and outside contracts is required
- 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 and travel
- Up to 50% travel is required
- 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
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.
Compensation details: 70000-90000 Yearly Salary
PI346466d843c9-25826-33730779
