Xtant Medical Holdings Inc
Quality Engineer II
Xtant Medical Holdings Inc, Belgrade, Montana, United States, 59714
Status:
Full Time, ExemptReports To:
Director of QualityA.
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 RelationshipThis position reports to the Director of Quality and may provide additional support to other departments as requested.C.
Duties and ResponsibilitiesSpecific 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 companySupport 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 Support of manufacturing activities from a Quality Engineering perspective in accordance with the requirements of 21 CFR 820, 21 CFR 1271, ISO 13485, and MDSAP (per jurisdictional areas)Communicate effectively with suppliers to resolve incoming documentation and quality issuesWork with all departments and divisions within Xtant to ensure adherence to Xtant’s Quality Management SystemSupport 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.Conduct validations, to include plans, protocols, reports, serving as a liaison-consultant to engineering and manufacturing teams throughout the design control processSupport 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 changesLead 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 modesParticipate as a team member on product and/or process development projects.Identify areas of opportunity for continual improvement and lean manufacturing throughout the facilitySupport the efforts of QA/RA Management to achieve departmental goals and quality objectivesManage and maintain Xtant Medical’s Design History Files & associated processesManage and maintain Xtant Medical’s Risk Management Files & associated processesParticipate in the following QMS activities:Nonconforming Product ManagementSupplier ManagementCorrective and Preventive ActionsInternal and External AuditsSterilization Validation/Dose AuditsOther QMS activities such as batch record review and product inspection (as applicable)May concurrently manage multiple projects and/or serve as the lead for these projects
Financial Responsibilities
Submit timely expense reports and abide by the Expense Reimbursement PolicyMaintain strict confidentiality of all company, customer and donor information
Training
Participate in training plans and programs and complete in a timely manner within set deadlinesComplete required training prior to attempting to perform a taskMaintain required training documentationComplete annual SOP review and OSHA safety training as applicableTrain and monitor the training of others in Department activities. May review and maintain employee training records
Management
This position does not supervise othersWork with and support the activities of the Senior Manager of Quality Engineering
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 requiredLegibly and accurately complete all documentation associated with assigned duties in accordance with GDP and review the written documentation of others as requiredWrite and revise a variety of technical documents including protocols, work instructions, standard operating procedures, forms, specifications, and training documentsMaintain information in physical and electronic files as requiredTrain on and demonstrate proficiency in Xtant Medical’s document control system
Other duties as assignedPerformance of Duties
Complete required training, including initial orientation and environmental health and safety training, prior to performing tasks.
Keep training up to datePerform all duties according to established procedures and follow appropriate safety precautions and measuresConduct himself/herself in a professional and courteous manner in all aspects of interaction with fellow employees, surgeons, staff, and end usersMaintain 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 SOPsMust maintain confidentiality of donor and recipient information according to HIPAA
D.
Job RequirementsEducation/Credentials Experience & TrainingMinimum of a Bachelor’s degree from an accredited college or university in Engineering or related technical field of studyMinimum of four (4) years’ experience in a Quality role, preferably in the Medical Device, Biologics, and/or pharmaceutical industriesMinimum of one (1) year of experience leading and executing Medical Device Risk Management and Design Control processesQuality certifications (e.g., CQT, CQPA), Lean manufacturing and/or Six Sigma certifications are preferredTechnical Requirements/SkillsAdvanced 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 solvingTechnical writing proficiency for creating, reviewing, approving protocols/reports, work instructions, forms, and SOPsAdvanced knowledge and experience in biologics manufacturing or other relevant cleanroom/aseptic environments. Advanced knowledge of volume and routine-manufacturing operationsProficient computer skills required such as basic knowledge of MS Word, Excel, PowerPoint, Outlook, and other software as necessary3.
Managerial ExperienceN/A4.
Special Requirements/Physical Capabilities or Abilities, other Additional Desirable QualificationsMust 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 ConditionsWorking 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 travelWork may require long periods of sitting, standing, and working at a computerWorking conditions may include a laboratory setting, environmentally controlled area (ECA), cleanrooms, and other sterile environmentsDuties 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 necessaryMay work in conditions leading to minor personal discomfort such as in temperatures above or below personal comfort levels.6.
Health and SafetyMust adhere to all health and safety requirements specified when entering laboratory and device manufacturing areas and in the handling of company productsThis 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 biohazardsMay require OSHA (bloodborne pathogen) training, SDS, and other safety training as applicableHepatitis 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 waiverMust 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 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
PIfe25747386a8-35216-33730781
Full Time, ExemptReports To:
Director of QualityA.
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 RelationshipThis position reports to the Director of Quality and may provide additional support to other departments as requested.C.
Duties and ResponsibilitiesSpecific 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 companySupport 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 Support of manufacturing activities from a Quality Engineering perspective in accordance with the requirements of 21 CFR 820, 21 CFR 1271, ISO 13485, and MDSAP (per jurisdictional areas)Communicate effectively with suppliers to resolve incoming documentation and quality issuesWork with all departments and divisions within Xtant to ensure adherence to Xtant’s Quality Management SystemSupport 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.Conduct validations, to include plans, protocols, reports, serving as a liaison-consultant to engineering and manufacturing teams throughout the design control processSupport 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 changesLead 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 modesParticipate as a team member on product and/or process development projects.Identify areas of opportunity for continual improvement and lean manufacturing throughout the facilitySupport the efforts of QA/RA Management to achieve departmental goals and quality objectivesManage and maintain Xtant Medical’s Design History Files & associated processesManage and maintain Xtant Medical’s Risk Management Files & associated processesParticipate in the following QMS activities:Nonconforming Product ManagementSupplier ManagementCorrective and Preventive ActionsInternal and External AuditsSterilization Validation/Dose AuditsOther QMS activities such as batch record review and product inspection (as applicable)May concurrently manage multiple projects and/or serve as the lead for these projects
Financial Responsibilities
Submit timely expense reports and abide by the Expense Reimbursement PolicyMaintain strict confidentiality of all company, customer and donor information
Training
Participate in training plans and programs and complete in a timely manner within set deadlinesComplete required training prior to attempting to perform a taskMaintain required training documentationComplete annual SOP review and OSHA safety training as applicableTrain and monitor the training of others in Department activities. May review and maintain employee training records
Management
This position does not supervise othersWork with and support the activities of the Senior Manager of Quality Engineering
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 requiredLegibly and accurately complete all documentation associated with assigned duties in accordance with GDP and review the written documentation of others as requiredWrite and revise a variety of technical documents including protocols, work instructions, standard operating procedures, forms, specifications, and training documentsMaintain information in physical and electronic files as requiredTrain on and demonstrate proficiency in Xtant Medical’s document control system
Other duties as assignedPerformance of Duties
Complete required training, including initial orientation and environmental health and safety training, prior to performing tasks.
Keep training up to datePerform all duties according to established procedures and follow appropriate safety precautions and measuresConduct himself/herself in a professional and courteous manner in all aspects of interaction with fellow employees, surgeons, staff, and end usersMaintain 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 SOPsMust maintain confidentiality of donor and recipient information according to HIPAA
D.
Job RequirementsEducation/Credentials Experience & TrainingMinimum of a Bachelor’s degree from an accredited college or university in Engineering or related technical field of studyMinimum of four (4) years’ experience in a Quality role, preferably in the Medical Device, Biologics, and/or pharmaceutical industriesMinimum of one (1) year of experience leading and executing Medical Device Risk Management and Design Control processesQuality certifications (e.g., CQT, CQPA), Lean manufacturing and/or Six Sigma certifications are preferredTechnical Requirements/SkillsAdvanced 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 solvingTechnical writing proficiency for creating, reviewing, approving protocols/reports, work instructions, forms, and SOPsAdvanced knowledge and experience in biologics manufacturing or other relevant cleanroom/aseptic environments. Advanced knowledge of volume and routine-manufacturing operationsProficient computer skills required such as basic knowledge of MS Word, Excel, PowerPoint, Outlook, and other software as necessary3.
Managerial ExperienceN/A4.
Special Requirements/Physical Capabilities or Abilities, other Additional Desirable QualificationsMust 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 ConditionsWorking 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 travelWork may require long periods of sitting, standing, and working at a computerWorking conditions may include a laboratory setting, environmentally controlled area (ECA), cleanrooms, and other sterile environmentsDuties 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 necessaryMay work in conditions leading to minor personal discomfort such as in temperatures above or below personal comfort levels.6.
Health and SafetyMust adhere to all health and safety requirements specified when entering laboratory and device manufacturing areas and in the handling of company productsThis 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 biohazardsMay require OSHA (bloodborne pathogen) training, SDS, and other safety training as applicableHepatitis 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 waiverMust 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 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
PIfe25747386a8-35216-33730781