Quality Assurance Engineering Manager jobs in Kansas

Quality Assurance Engineering Manager manages inspections of raw materials, equipment, processes, and finished products. Implements quality standards and protocols for quality assurance testing models. Being a Quality Assurance Engineering Manager assists in the design and implementation of policies and procedures for testing and evaluating the precision and accuracy of products and/or equipment. Ensures projects are completed on time and within budget. Additionally, Quality Assurance Engineering Manager acts as a technical advisor to quality assurance engineering team regarding projects, tasks, and operations. Requires a bachelor's degree. Typically reports to a head of a unit/department. The Quality Assurance Engineering Manager manages subordinate staff in the day-to-day performance of their jobs. True first level manager. Ensures that project/department milestones/goals are met and adhering to approved budgets. Has full authority for personnel actions. To be a Quality Assurance Engineering Manager typically requires 5 years experience in the related area as an individual contributor. 1 - 3 years supervisory experience may be required. Extensive knowledge of the function and department processes. (Copyright 2024 Salary.com)

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Quality Assurance Manager
  • University of Kansas Medical Center
  • Kansas, KS FULL_TIME
  • Department:
    SOM KC Cancer Center Administration
    -----
    KMCRI-Administration

    Position Title:
    Quality Assurance Manager

    Job Family Group:
    Professional Staff

    Job Description Summary:
    Under the direction of the Quality Assurance Project Manager, The University of Kansas Cancer Center (KUCC) Quality Assurance Manager will work to ensure the Clinical Trial Organization (CTO) established standard processes and procedures are being followed and maintained. Along with the QA team, the QA Manager provides quality control support, assistance and direction for clinical trials supported by KUCC or where KUCC is a participating site. In partnership with the Clinical Trials Office, the QA Team assures clinical trials are being conducted in accordance with Institutional and Regulatory guidelines; therefore, achieving quality and efficacious data and positive clinical outcome with the ultimate goal of innovative, safe, and quality care for cancer patients.

    The University of Kansas Cancer Center is the region's only National Cancer Institute-designated cancer center where patients gain access to the most promising therapies, cutting-edge clinical trials and world class research.

    Job Description:
    Conditions of Employment: Minimal travel to attend national meetings, etc.

    Required Qualifications

    Education: Bachelor's degree in life sciences or related field.

    Work Experience:
    Experience with FDA regulations relevant to drugs, devices, biologics.
    Experience with CAPA (Corrective Action and Preventive Action) plans and responses.
    Experience with clinical trial monitoring and/or auditing.
    Experience with and understanding of medical, laboratory, and clinical trial concepts and terminology.
    Computer experience including Microsoft Word, Excel and Access applications.

    Preferred Qualifications

    Work Experience:
    5 or more years clinical research experience Previous working knowledge and experience with the FDA inspections and Pharmaceutical sponsors audits.
    Previous working knowledge and experience with the FDA inspections and Pharmaceutical sponsors audits.
    Experience with clinical management database systems utilizing tables, queries, etc.

    Skills:
    Attention to detail with excellent analytical and problem-solving skills.
    Work effectively under periodically stressful conditions.
    Manage multiple tasks and set priorities and meet deadlines.
    Work within a team approach and be motivated to work consistently in a fast-paced, "customer-focused" environment.
    Excellent organizational and communication skills.

    Job Duties Outlined:
    Perform internal audits of the Investigator Initiated Clinical Trials (IITs) conducted at the University of Kansas Cancer Center to ensure protocol compliance, and adherence to Clinical Trials Office Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and the applicable Institutional and Regulatory guidelines and requirement(s).
    Work collaboratively with Principal Investigator, CTO Project Directors and other study team members to address concerns following internal and external audits.
    Interact with Pharmaceutical company sponsor Quality Assurance auditors, Clinical Research Organization (CRO) auditors Cooperative group nurse auditors, and other academic institution QA teams in the scheduling, preparation and hosting of external audits both onsite and remote.
    Serve as the primary point of contact for internal audits, external audits, FDA and other Regulatory agency Inspections prior to, during and following conclusion of the audit or inspection.
    Responsible for the preparation of external audits by conducting objective, high level review of clinical trial information managed by the KU Cancer Center, including Cooperative groups, and Pharmaceutical sponsored clinical trials in preparation for external audits.
    Collaborate with Principal Investigator, Clinical study team, Regulatory team, Correlative Laboratory and Investigational Drug Services in preparation of external audits and Regulatory Inspection.
    Be knowledgeable, stay current, and act accordingly within the framework of Regulatory guidelines provided by Federal, State, and local regulatory agencies and ethical guidelines pertaining to the clinical research industry.
    Act as a Quality Assurance resource to clients of the KU Cancer Center, evaluate problems and provide solutions.
    Responsible for ongoing individual and group training and development of staff, mentoring and coaching, and adherence to organizational policies and procedures as assigned by Director of Quality Assurance.
    Ensure the effectiveness of the KUCC Quality Assurance team by establishing positive and professional relationships with the KU Cancer Center Principal Investigators, Clinical Trials Office staff including CTO Leadership, Senior Management, Project Management, Clinical Research Coordinators, Clinical Research Data Coordinators, KU Health System staff members and maintain these relationships through constructive and non-punitive communication.
    Participate in SIVs and kick-off meetings to represent quality assurance objectives as assigned by the Director of Quality Assurance.
    Identify project issues and suggest possible solutions; manage problem resolution through expedient and corrective means.
    Investigate and respond to CAPA (Corrective Action and Preventive Action) requests by collaborating with Clinical Trials Office study team members, Investigational Drug Services, Correlative Laboratory and other teams involved with the audit.
    Provide support to the Data Safety Monitoring Committee Coordinator (DSMC) by generating and reviewing reports, creating meeting agenda, and attending quarterly meetings.
    Perform other duties as assigned.

    Required Documents:
    Must provide Cover letter and Resume

    Comprehensive Benefits Package:
    Coverage begins on day one for health, dental, and vision insurance and includes health expense accounts with generous employer contributions if the employee participates in a qualifying health plan. Employer-paid life insurance, long-term disability insurance, and various additional voluntary insurance plans are available. Paid time off, including vacation and sick, begins accruing upon hire, plus nine paid holidays. One paid discretionary day is available after six months of employment, and paid time off for bereavement, jury duty, military service, and parental leave is available after 12 months of employment. A retirement program with a generous employer contribution and additional voluntary retirement programs (457 or 403b) are available. https://www.kumc.edu/human-resources/benefits.html

    Employee Type:
    Regular

    Time Type:
    Full time

    Rate Type:
    Salary

    Compensation Statement:
    The pay range listed for this position is determined by our compensation program using market data and salary benchmarking. A combination of factors is considered in making compensation decisions including, but not limited to, education, experience and training, qualifications relative to the requirements of the position, and funding. At the University of Kansas Medical Center, a reasonable estimate for the starting pay range will be the minimum to midpoint of the posted range, taking into account the combination of factors listed above.

    Pay Range:
    $58,000.00 - $86,000.00
    Minimum
    $58,000.00
    Midpoint
    $72,000.00
    Maximum
    $86,000.00

    Application Instructions:
    To learn more and apply online, please visit https://kumc.wd5.myworkdayjobs.com/en-US/kumc-jobs/job/Kansas-City-Metro-Area/Quality-Assurance-Manager_JR005916 or go to https://careers.kumc.edu/ and search for position number JR005916.

    Applications must be submitted directly through the KU Medical Center website to be considered for this position. Any applications submitted via email or this website will NOT be reviewed or considered.

    About KU Medical Center:
    The University of Kansas Medical Centers mission is to educate exceptional health care professionals through a full range of undergraduate, graduate, professional, postdoctoral and continuing education programs in the schools of Medicine, Nursing and Health Professions. KU Medical Center also advances the health sciences through world-class research programs; provides compassionate and state-of-the-art patient care in an academic medical center environment; and works with communities in every Kansas county to improve the health of Kansans. Learn more at www.kumc.edu .

    Benefits:
    KUMC offers a range of great benefits that support employees and eligible family members. Our health insurance benefits begin on hire date and KUMC offers other exciting benefits such as paid parental leave, generous employer retirement contributions and other resources to improve health and well-being. For more information, please visit https://www.kumc.edu/human-resources/benefits.html

    KU is an EO/AAE. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, national origin, disability, genetic information or protected Veteran status. http://policy.ku.edu/IOA/nondiscrimination

    jeid-578b97496bcbe34381df633877f233dd
  • 17 Days Ago

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Quality Assurance Manager
  • GPac
  • Kansas, KS FULL_TIME
  • Salary: $95k - 142k per year Health/ Den/ Vis/ 401k Reference: TB-ATS-KC-QA-Mgr-02 Quality Assurance Manager- Aviation Manufacturing SUMMARY: The Quality Assurance Manager is responsible for the opera...
  • 4 Days Ago

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Quality Assurance Manager
  • Cox Machine, Inc.
  • Wichita, KS FULL_TIME
  • Quality Manager Cox Machine, headquartered in Wichita Kansas, is a leading manufacturer of precision parts and assemblies for the aerospace, deep space, and semiconductor industries. Cox Machine is le...
  • 5 Days Ago

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Quality Assurance Manager
  • Union Tank Car Company - UTLX
  • El Dorado, KS FULL_TIME
  • Who We Are: The Company’s regulatory, engineering and commercial expertise make UTLX the preferred source of railcars and services for many of its customers. Owned by the Marmon Group and Berkshire Ha...
  • 7 Days Ago

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Quality Assurance Manager
  • Max Aerostructures Llc
  • Wichita, KS FULL_TIME
  • As a Quality Manager, you will play a crucial role in ensuring that our organization maintains the highest standards of quality in all aspects of its operations. You will be responsible for overseeing...
  • 19 Days Ago

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Quality Control/Assurance Manager
  • Chanute Manufacturing
  • Chanute, KS FULL_TIME
  • Chanute Manufacturing Company has an immediate opening for a QC/QA Manager. The qualified candidate should have a working experience in the steel fabrication industry with knowledge of ASME Section I ...
  • 19 Days Ago

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Quality Engineering Manager
  • Company Confidential
  • Global polymers company is seeking a Plant Quality Manager for one of it's manufacturing locations in the Greater Clevel...
  • 4/19/2024 12:00:00 AM

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Quality Engineering Manager
  • JMJ Phillip Group
  • A leading organization in the Heavy Equipment Manufacturing Industry is seeking an Advanced Quality Engineering Manager ...
  • 4/19/2024 12:00:00 AM

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Quality Engineering Manager
  • Honeywell
  • Olathe, KS
  • Innovate to solve the world's most important challenges Lead a team that applies its expertise and knowledge in finding ...
  • 4/18/2024 12:00:00 AM

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Quality Engineering Manager
  • Germer International - Pharmaceutical Recruiting
  • Richmond, VA
  • The Quality Assurance Engineering Manager will join a newly formed team at our client’s brand-new site by bringing their...
  • 4/17/2024 12:00:00 AM

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Quality Engineering Manager
  • Confidential
  • Elkhorn, WI
  • We are looking for an experienced Quality Manager to ensure that our products and services meet all necessary requiremen...
  • 4/17/2024 12:00:00 AM

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Sr Manager Quality Engineering
  • PCI Pharma Services
  • Rockford, IL
  • Summary of Objective: The Sr. Quality Engineer Manager will manage a team of Quality professionals to provide Quality En...
  • 4/17/2024 12:00:00 AM

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Quality Assurance Engineering Manager
  • EG Workforce Solutions
  • Grand Rapids, MI
  • Job Description Job Description Come and put your Quality Management skills to work with a great company in the area! If...
  • 4/16/2024 12:00:00 AM

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Quality Engineering Manager
  • Honeywell
  • Olathe, KS
  • Innovate to solve the world's most important challenges Lead a team that applies its expertise and knowledge in finding ...
  • 4/15/2024 12:00:00 AM

Kansas /ˈkænzəs/ (listen) is a U.S. state in the Midwestern United States. Its capital is Topeka and its largest city is Wichita, with its most populated county being Johnson County. Kansas is bordered by Nebraska on the north; Missouri on the east; Oklahoma on the south; and Colorado on the west. Kansas is named after the Kansa Native American tribe, which inhabited the area. The tribe's name (natively kką:ze) is often said to mean "people of the (south) wind" although this was probably not the term's original meaning. For thousands of years, what is now Kansas was home to numerous and divers...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Quality Assurance Engineering Manager jobs
$119,985 to $149,103

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