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/ResponsibilitiesDevelop 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 PolicyMaintain 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 SOPsDevelop 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 applicableAdhere to Xtant Medical Standard Operating Procedures (SOPs), Good Documentation Practices (GDP), and safety protocolsComplete 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 SystemManage 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 scheduleSupport new supplier evaluation and qualification including inspection and first articlesMeasure, analyze, and improve supplier performance and reduce supplier nonconformancesWork to resolve supplier technical issues in a timely manner to ensure continuity of supplyConduct receiving inspections, in-process inspections and finished device inspectionsInspecting and monitoring receiving, in-process, and final product control results including collection and testing of representative samplesParticipate in and help lead successful external audits (FDA, ISO, etc.). Serve as a liaison between QA/RA Management and the auditor(s) during regulatory inspectionsPerform and participate in validations as neededParticipate in design control as neededHelp to accomplish quality objectives and develop quality standardsPerform and manage Internal Audits as directed by QA/RA ManagementParticipate in Complaint, Deviation, Nonconformance, and CAPA investigations as necessarySupport the efforts of QA/RA Management to achieve departmental goals and quality objectivesFinancial ResponsibilitiesMaintain strict confidentiality of all company, customer, and donor informationSubmit timely expense reports and abide by the Expense Reimbursement PolicyTrainingComplete required training prior to performing tasks, including initial orientation and environmental health and safety training. Keep training up to datePerform 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 recordsManagementThis position does not supervise othersWork with and support the activities of QA/RA ManagementHelp direct the activities of Department employees to accomplish quality and company objectivesAssist in the hiring of skilled, responsible, and ethical individuals for the Department as necessaryDocument Control and Record ControlAssist in the completion and retention of documentation pertaining to all SOPs as requiredLegibly 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 assignedMaintain information in physical and electronic files as requiredTrain on and demonstrate proficiency in Xtant Medical’s document control systemOther duties as assignedPerformance of DutiesPerform all duties according to established procedures and follow appropriate safety precautions and measuresRepresent 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 usersMaintain a clean and safe working environment at all timesMust maintain confidentiality of donor and recipient information according to HIPAAD. Job Requirements
Education/Credentials Experience & TrainingBachelor's degree in biology-related, engineering or an equivalent course of study is requiredFive plus (5+) years’ experience in medical device, biologics, orthopedic or health industry quality assurance is preferredCorrective/preventive action, root cause analysis, effectiveness check, statistical application experience and training is requiredISO 13485 Lead Auditor Certificate is preferredASQ Certified Quality Auditor Certificate is preferredSix-sigma black-belt certification is preferredGeneral knowledge of ISO 13485 and FDA Quality System Regulation guidelines required, advanced knowledge is preferredRegulatory and Quality auditing training and experience is requiredExperience and high level of proficiency in Microsoft Office Suite is requiredExperience with records maintenance and document controlExperience in regulatory standards, regulatory inspection hosting, GLP, GMP and GDPHigh level of attention to detail and accuracy is requiredStrong organizational skills and ability to prioritize tasks is requiredExceptional documentation and technical writing skills is requiredExcellent verbal and written English language skills is requiredKnowledge of FDA, ISO, and AATB requirementsAbility to write, review, and edit technical reports and SOPsMust possess excellent organizational skills and strong attention to detailAbility 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 needsProficient computer skills required such as basic knowledge of MS Word, Excel, PowerPoint, Outlook, and other software as necessaryAdvanced ability to communicate effectively both orally and in writing and the ability to present effectively to small and large groupsAbility to assist in the development and presentation of educational programs and/or workshopsStrong leadership and interpersonal skills and the ability to effectively communicate with a wide range of individuals in a diverse communityAbility to investigate and analyze information and to draw conclusions3. 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.
70000.00 To 90000.00 (USD) Annually
