Xtant Medical
Quality Assurance Analyst I
Xtant Medical, Belgrade, Montana, United States, 59714
At
Xtant Medical , our mission is to honor the gift of donation by allowing our patients to live as full and complete a life as possible. We are seeking a full-time, non-exempt Quality Assurance Analyst to join our team on-site in Belgrade, MT. It offers a pay rate of $25.75 - $33.11 hourly (DOE) and includes the benefits listed below. If you enjoy working as a team and want to grow your career, you’ve found the right place at Xtant Medical!
Benefits:
Medical-Dental-VisionGenerous PTO ScheduleCorporate Gym Discount401(k)Well-Being Programs / LifeBalance Discount ProgramLife & AD&D Life InsuranceLong-Term & Short-Term DisabilityTax Savings, plus more...Responsibilities of the Quality Assurance Analyst I:
Communicate effectively with suppliers to resolve incoming documentation and quality issuesSupport 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)Review Device History/Batch Records for accuracy, completeness and conformance with documented specifications and procedures. Perform in-process and final review and release of Processing and/or hardware batch recordsPerform label review/approval, inspection of WIP product, and receiving inspection and testing on materials and outsourced finished goods using applicable specifications, procedures, and related equipment (Sartorious Balance, Smartscope, comparator, calipers, micrometers, etc.)Perform routine review of records including, but not limited to:
Lyophilization logsEquipment records (calibration certificates, return to service inspections, equipment qualification, etc.)Receiving inspectionFacility cleaning logsReturns processingEnvironmental monitoring
Participate in QMS Activities including, but not limited to:
Error and Nonconformance Management processCorrective Action and Preventive Action (CAPA) processQuality Planning processPlanned Deviation processSupplier Qualification processChange Control processEngineering StudiesValidation activitiesDocument Control
Participate in and demonstrate a general understanding of the sterilization validation process and applicable requirementsParticipate in Dose Audit/Routine Bioburden Monitoring including working with outsourced laboratories for quotes, sample requests, collection, sample submission and result reviews and trendingParticipate in routine product testing: (e.g., Osteoinductivity, Endotoxin, Residual Calcium and Residual Moisture Testing) including sample collection, submission, results analysis/review, and trendingParticipate in product or process development/improvement initiativesAssist Department in conducting investigations, root cause analysis and development of corrective/preventive action plansParticipate in internal audits and regulatory inspectionsNew product code creationWrite and revise SOPs, Work Instructions, Forms, etc.Participate in record control, scanning and archiving processesParticipate in risk management and design controlRequirements for the Quality Assurance Analyst I:
Bachelor’s degree from an accredited college or university is preferredMinimum of two (2) years’ experience directly related to the duties and responsibilities specified in a regulated manufacturing environment. Previous medical device or HCT/P manufacturing is preferredProfessional certification (CQT-Certified Quality Technician, CQA-Certified Quality Auditor, CMDA-Certified Medical Device Auditor, CQPA-Certified Quality Process Analyst) is preferred, or must possess willingness to obtainCertified Tissue Bank Specialist (CTBS) certification is preferred, or must possess willingness to obtainISO 13485 Lead Auditor Training is preferred, or must possess willingnessProficiency with operation and use of all computer software necessary to execute duties including, but not limited to, ERP, MS Word, Excel, Power Point, Outlook, TeamsWorking Conditions
Working conditions are normal for an office environment. Standard office hours are Monday – Friday; 8:00 am – 5:00 pmWork may require long periods of sitting and working at a computer, and 4+ hours of standingWorking conditions may include a laboratory setting, environmentally controlled area (ECA), cleanrooms, and other sterile environmentsWork may require occasional weekend/evening work and travelDuties may include contact with human tissue, blood, bone, and fluidsHealth and Safety
Must 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 waiver
About Us:
We aim to improve the quality of life for our patients by designing, manufacturing and distributing medical devices and human tissues for transplants that are safe, effective and meet the needs of our customers.
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.
Xtant Medical , our mission is to honor the gift of donation by allowing our patients to live as full and complete a life as possible. We are seeking a full-time, non-exempt Quality Assurance Analyst to join our team on-site in Belgrade, MT. It offers a pay rate of $25.75 - $33.11 hourly (DOE) and includes the benefits listed below. If you enjoy working as a team and want to grow your career, you’ve found the right place at Xtant Medical!
Benefits:
Medical-Dental-VisionGenerous PTO ScheduleCorporate Gym Discount401(k)Well-Being Programs / LifeBalance Discount ProgramLife & AD&D Life InsuranceLong-Term & Short-Term DisabilityTax Savings, plus more...Responsibilities of the Quality Assurance Analyst I:
Communicate effectively with suppliers to resolve incoming documentation and quality issuesSupport 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)Review Device History/Batch Records for accuracy, completeness and conformance with documented specifications and procedures. Perform in-process and final review and release of Processing and/or hardware batch recordsPerform label review/approval, inspection of WIP product, and receiving inspection and testing on materials and outsourced finished goods using applicable specifications, procedures, and related equipment (Sartorious Balance, Smartscope, comparator, calipers, micrometers, etc.)Perform routine review of records including, but not limited to:
Lyophilization logsEquipment records (calibration certificates, return to service inspections, equipment qualification, etc.)Receiving inspectionFacility cleaning logsReturns processingEnvironmental monitoring
Participate in QMS Activities including, but not limited to:
Error and Nonconformance Management processCorrective Action and Preventive Action (CAPA) processQuality Planning processPlanned Deviation processSupplier Qualification processChange Control processEngineering StudiesValidation activitiesDocument Control
Participate in and demonstrate a general understanding of the sterilization validation process and applicable requirementsParticipate in Dose Audit/Routine Bioburden Monitoring including working with outsourced laboratories for quotes, sample requests, collection, sample submission and result reviews and trendingParticipate in routine product testing: (e.g., Osteoinductivity, Endotoxin, Residual Calcium and Residual Moisture Testing) including sample collection, submission, results analysis/review, and trendingParticipate in product or process development/improvement initiativesAssist Department in conducting investigations, root cause analysis and development of corrective/preventive action plansParticipate in internal audits and regulatory inspectionsNew product code creationWrite and revise SOPs, Work Instructions, Forms, etc.Participate in record control, scanning and archiving processesParticipate in risk management and design controlRequirements for the Quality Assurance Analyst I:
Bachelor’s degree from an accredited college or university is preferredMinimum of two (2) years’ experience directly related to the duties and responsibilities specified in a regulated manufacturing environment. Previous medical device or HCT/P manufacturing is preferredProfessional certification (CQT-Certified Quality Technician, CQA-Certified Quality Auditor, CMDA-Certified Medical Device Auditor, CQPA-Certified Quality Process Analyst) is preferred, or must possess willingness to obtainCertified Tissue Bank Specialist (CTBS) certification is preferred, or must possess willingness to obtainISO 13485 Lead Auditor Training is preferred, or must possess willingnessProficiency with operation and use of all computer software necessary to execute duties including, but not limited to, ERP, MS Word, Excel, Power Point, Outlook, TeamsWorking Conditions
Working conditions are normal for an office environment. Standard office hours are Monday – Friday; 8:00 am – 5:00 pmWork may require long periods of sitting and working at a computer, and 4+ hours of standingWorking conditions may include a laboratory setting, environmentally controlled area (ECA), cleanrooms, and other sterile environmentsWork may require occasional weekend/evening work and travelDuties may include contact with human tissue, blood, bone, and fluidsHealth and Safety
Must 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 waiver
About Us:
We aim to improve the quality of life for our patients by designing, manufacturing and distributing medical devices and human tissues for transplants that are safe, effective and meet the needs of our customers.
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.