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-Vision
- Generous PTO Schedule
- Corporate Gym Discount
- 401(k)
- Well-Being Programs / LifeBalance Discount Program
- Life & AD&D Life Insurance
- Long-Term & Short-Term Disability
- Tax Savings, plus more...
Responsibilities of the Quality Assurance Analyst I:
- Communicate effectively with suppliers to resolve incoming documentation and quality issues
- 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)
- 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 records
- Perform 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 logs
- Equipment records (calibration certificates, return to service inspections, equipment qualification, etc.)
- Receiving inspection
- Facility cleaning logs
- Returns processing
- Environmental monitoring
- Participate in QMS Activities including, but not limited to:
- Error and Nonconformance Management process
- Corrective Action and Preventive Action (CAPA) process
- Quality Planning process
- Planned Deviation process
- Supplier Qualification process
- Change Control process
- Engineering Studies
- Validation activities
- Document Control
- Participate in and demonstrate a general understanding of the sterilization validation process and applicable requirements
- Participate in Dose Audit/Routine Bioburden Monitoring including working with outsourced laboratories for quotes, sample requests, collection, sample submission and result reviews and trending
- Participate in routine product testing: (e.g., Osteoinductivity, Endotoxin, Residual Calcium and Residual Moisture Testing) including sample collection, submission, results analysis/review, and trending
- Participate in product or process development/improvement initiatives
- Assist Department in conducting investigations, root cause analysis and development of corrective/preventive action plans
- Participate in internal audits and regulatory inspections
- New product code creation
- Write and revise SOPs, Work Instructions, Forms, etc.
- Participate in record control, scanning and archiving processes
- Participate in risk management and design control
Requirements for the Quality Assurance Analyst I:
- Bachelor’s degree from an accredited college or university is preferred
- Minimum 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 preferred
- Professional 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 obtain
- Certified Tissue Bank Specialist (CTBS) certification is preferred, or must possess willingness to obtain
- ISO 13485 Lead Auditor Training is preferred, or must possess willingness
- Proficiency with operation and use of all computer software necessary to execute duties including, but not limited to, ERP, MS Word, Excel, Power Point, Outlook, Teams
Working Conditions
- Working conditions are normal for an office environment. Standard office hours are Monday – Friday; 8:00 am – 5:00 pm
- Work may require long periods of sitting and working at a computer, and 4+ hours of standing
- Working conditions may include a laboratory setting, environmentally controlled area (ECA), cleanrooms, and other sterile environments
- Work may require occasional weekend/evening work and travel
- Duties may include contact with human tissue, blood, bone, and fluids
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
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.
25.75 To 33.11 (USD) Hourly
