Total Quality Analyst jobs in Montana

Total Quality Analyst assists with the administration of the organization's total quality programs and processes. Conducts reviews and inspections of internal and vendor processes and activities to monitor compliance. Being a Total Quality Analyst collects data and prepares documents and charts to report status of programs. May be certified in methodologies such as Six Sigma, Lean, or Kaizen. Additionally, Total Quality Analyst typically requires a bachelor's degree in area of specialty. Typically reports to a manager or head of a unit/department. The Total Quality Analyst occasionally directed in several aspects of the work. Gains exposure to some of the complex tasks within the job function. To be a Total Quality Analyst typically requires 2 -4 years of related experience. (Copyright 2024 Salary.com)

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Quality Assurance Analyst I
  • Xtant Medical
  • Belgrade, MT FULL_TIME
  • 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.
  • 10 Days Ago

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GPS Operations Transformation Healthcare Quality Analyst
  • Deloitte
  • Helena, MT FULL_TIME
  • Are you looking to make an immediate impact where you can help our clients solve their business challenges? Deloitte's Core Business Operations (CBO) portfolio operates at the center of our client's b...
  • 1 Day Ago

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Total Joint Program Coordinator
  • Billings Clinic Health System
  • Billings, MT OTHER
  • The incumbent in thisposition is responsible for the development, implementation, and evaluation ofthe total joint program at Billings Clinic. This individual works in closecollaboration with the tota...
  • 3 Days Ago

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Total Station Trimble Operator
  • Williams Plumbing / Williams Civil Construction
  • Bozeman, MT FULL_TIME
  • Williams is hiring a Total Station Trimble Operator! The Total Station Trimble Operator is responsible for accurately coordinating layout, physical coordination, building corners and setbacks of plumb...
  • 2 Months Ago

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Tech I - IPSC
  • Total Safety
  • Billings, MT FULL_TIME
  • Total Safety is looking for a IPSC Technician to join their safety conscious team! The IPSC Technician works under the direction of a supervisor in a plant environment and provides a variety of servic...
  • 4 Days Ago

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Eye Care Technician (no technician experience necessary)
  • Total Eyecare
  • Billings, MT FULL_TIME
  • Are you looking for an opportunity to share your passion for customer service in an efficient, patient-focused environment? At Total EyeCare Billings, our Vision is to make each person feel like the m...
  • 18 Days Ago

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Data Quality Analyst
  • Saxon Global
  • San Leandro, CA
  • Data Quality Analyst - on site 2023 (Sr. role) Position Overview: This QA role is to ensure that the solution delivered ...
  • 6/10/2024 12:00:00 AM

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MD_Process Quality Analyst
  • Innova solutions
  • Charlotte, NC
  • Position type: Full-timeContract Location: Hybrid - Charlotte, NC No C2C. W2 contractors only. As a Process Quality Anal...
  • 6/10/2024 12:00:00 AM

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Quality Analyst
  • Mallinckrodt
  • Madison, AL
  • Job Title Quality Analyst Requisition JR000014219 Quality Analyst (Open) Location CC-Madison - USA503 Additional Locatio...
  • 6/9/2024 12:00:00 AM

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Data quality analyst
  • Procom
  • Tampa, FL
  • Data Quality Analyst On behalf of our client in the Financial Services Sector, Procom is seeking a Data Quality Analyst....
  • 6/9/2024 12:00:00 AM

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Call Quality Analyst
  • Aaron's
  • Atlanta, GA
  • We are Aaron's - an industry leader in the sales and lease-to-own retail industry known for quality brand names and supe...
  • 6/9/2024 12:00:00 AM

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Data Quality Analyst
  • Apex Systems
  • Richmond, VA
  • Data Quality Analyst Large Banking Client Hybrid 2-3x/week onsite in Chicago IL OR Denver CO 12+ month contract On a W2 ...
  • 6/8/2024 12:00:00 AM

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Quality Analyst
  • Saxon Global
  • Brooklyn, NY
  • HRA JOB TITLE: Quality Analyst_1 - 4 Required Skills Minimum 4 Years Experience in Business/Quality Analysis tools such ...
  • 6/8/2024 12:00:00 AM

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Data Quality Analyst
  • Mindlance
  • Tampa, FL
  • Data Quality Analyst - Only W2 Duration: 12 months (possible extension or conversion) Location: Hybrid with onsite requi...
  • 6/7/2024 12:00:00 AM

Montana (/mɒnˈtænə/ (listen)) is a landlocked state in the Northwestern United States. Montana has several nicknames, although none are official, including "Big Sky Country" and "The Treasure State", and slogans that include "Land of the Shining Mountains" and more recently "The Last Best Place". Montana is the 4th largest in area, the 8th least populous, and the 3rd least densely populated of the 50 U.S. states. The western half of Montana contains numerous mountain ranges. Smaller island ranges are found throughout the state. In all, 77 named ranges are part of the Rocky Mountains. The easte...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Total Quality Analyst jobs
$64,902 to $83,920

Total Quality Analyst in Buffalo, NY
Responsible for delivering the Total Quality Management initiatives in its entirety in addition to other initiatives to improve manufacturing performance that is part of the long-term.
January 31, 2020
Total Quality Analyst in Chico, CA
(B) Ensure that the definition of quality is understood and internalized by the employees.
February 14, 2020
Total Quality Analyst in Troy, NY
A quality management system is an established framework where businesses can manage its key processes.
February 17, 2020