Software Quality Assurance Director jobs in Nevada

Software Quality Assurance Director directs and oversees the implementation of policies and procedures for the software quality assurance function. Evaluates and monitors tools, methodologies, and automation to ensure effective testing and identification of defects. Being a Software Quality Assurance Director oversees user acceptance, alpha, and beta testing efforts. Requires a bachelor's degree. Additionally, Software Quality Assurance Director reports to top management. The Software Quality Assurance Director typically manages through subordinate managers and professionals in larger groups of moderate complexity. Provides input to strategic decisions that affect the functional area of responsibility. May give input into developing the budget. To be a Software Quality Assurance Director typically requires 3+ years of managerial experience. Capable of resolving escalated issues arising from operations and requiring coordination with other departments. (Copyright 2024 Salary.com)

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Director of Quality Assurance
  • Hamilton Medical, Inc.
  • Reno, NV OTHER
  • Company Overview

    Hamilton Medical was founded with a vision: To develop intelligent ventilation solutions that make life safer for patients in critical care and easier for the people who care for them. Today, Hamilton Medical is a leading manufacturer of critical care ventilation solutions for a wide variety of patient populations, applications, and environments.

    Responsibilities

    The Director of Quality Assurance is responsible for contributing to the growth and sustainability of Hamilton Medical, Inc. by assuring that quality levels of the Company's products conform to Hamilton Medical, regulatory, and customer standards at optimum cost while ensuring compliance with all regulatory requirements.

     

    RESPONSIBILIITES

    • Provide value-added and solution-based support by implementing policies and procedures to maintain and improve manufacturing practices toward quality in a Medical Device and Scientific Equipment environment, ensuring that product meets corporate, regulatory, and customer standards.
    • Maintain a system-wide Quality Assurance Program compliant with FDA regulations and other relevant global standards, including ISO 13485.
    • Complete and issue European Declarations of Conformity, including declarations for Ventilators.
    • Work with Product Management to supply complete documentation for customer FDA submissions.
    • Provide company-wide Quality System training to ensure a quality-oriented labor force.
    • Implement compliance programs for OSHA, EPA, local Fire Department, and other Safety/Environmental agencies.
    • Conduct product recalls, including customer notifications and any required FDA, Health Canada, or other global agency communications, as necessary.
    • Conduct system-wide audits (system, process, safety/environmental, and stock audits) of all processes and methods used in the design, promotion, manufacture, packaging, storage, and distribution of product to assure that all quality standards are being met.
    • Work with department heads on planning and implementation of resolutions and risk mitigations.
    • Prepare and distribute reports on quality metrics to management and suggest appropriate improvements and corrective actions.
    • Maintain close liaison activity and cooperation with U.S. and Swiss Hamilton Medical teams such as: Product Management, R&D, Operations, and Marketing.
    • Staff and maintain a well-trained work force team at levels appropriate in accordance with established policies and procedures. Develop management and technical skills to preclude technical obsolescence.
    • Contribute to cost reduction program by implementing cost savings based on analysis of defect history and customer service reports, and evaluations of product specs.
    • Prepare and administer approved departmental operating budgets, long range goals, and ensure that it is complied with.
    • Personally control and handle government, customer, and other quality related audits, including reporting and advising corrective action.
    • Act as Management Representative for the Quality System (pursuant to FDA's 21 CFR 820 and ISO 13485).
    • Work closely with Swiss parent company, Hamilton Medical, AG, to coordinate and harmonize quality and regulatory systems and objectives.
    • Work with product management and outside legal counsel on customer-related legal affairs.
    • Manage/oversee a Principal Regulatory Affairs and Quality position.
    • Advice on and coordinate the approval of high-level registration of medical devices.
    • Other duties as assigned.

    MANAGEMENT REPRESENTATIVE RESPONSIBILITIES

    Top management shall appoint a member of management who, irrespective of other responsibilities, has responsibility and authority that includes:

    • Ensure that processes needed for the quality management system are documented.
    • Report to top management on the effectiveness of the quality management system and any need for improvements.
    • Ensure the promotion of awareness of applicable regulatory requirements and quality management system requirements throughout the organization.

    The Management Representative currently appointed is the Director of Quality and Regulatory.

    Qualifications

    • Expert knowledge of Medical Device Regulatory Requirements (U.S. FDA, EU, and other applicable global agencies), Quality System requirements, and of physical measurements and statistical methods.
    • Strong and credible reputation with peers, with the FDA and other regulatory agencies, with customers, and with registrars.
    • Track record of managing and completing projects and tasks on time and within budget.
    • Accountable for the success or failure of the total quality assurance operation and for the proper expenditure and management of annual budget.
    • Position requires exerting up to 10 pounds of force occasionally and/or negligible amount of force to lift, carry, push, pull, or otherwise move objects.

    Education/Experience

    • B.S. or M.S. in Physical Science, Engineering, or related field required.
    • Minimum of ten years industrial quality assurance experience required.
    • Minimum of three years management at department level required.

    Additional Information

    • Anticipated salary range is $131,000 - $243,000/year.
    • Diverse portfolio of exciting and innovative design projects.
    • Tremendous opportunities for professional growth.
    • Commitment to sustainable design.
    • Competitive compensation.
    • Excellent benefit package includes medical, dental, vision insurance, paid vacation time, paid sick time, disability insurance, 401k, tuition reimbursement and more.
    • Solid stable company.
    • Must pass drug and background screens.
    • May be required to wear Personal Protective Equipment (provided by employer).

    Mid Salary

    USD $187,200.00/Yr.
  • 10 Days Ago

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Director of Quality Assurance
  • ProCaps Laboratories
  • Henderson, NV FULL_TIME
  • WHO WE ARE For over 40 years, ProCaps Laboratories has understood that people are becoming more mindful of what they put into their bodies to improve their health. From its inception, the company’s go...
  • 1 Month Ago

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Software Quality Assurance Tester Intern - LV
  • The GLI Group
  • Las Vegas, NV INTERN
  • While providing integrity to the casino and gambling industry for over 34 years, GLI has established an incomparable team of professionals. Join a global market leader in the gambling industry while g...
  • 1 Month Ago

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Quality Assurance / Quality Control
  • Loenbro, LLC
  • Elko, NV FULL_TIME
  • Position: Quality Assurance / Quality Control Company: Loenbro Industrial Services Location: Elko, NV Reports To: Quality Control Regional Manager Wage: $32/hr to $45/hr DOE We are looking for an expe...
  • 6 Days Ago

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Independent Medicare Insurance Broker - Work from Home
  • Assurance
  • Nevada, NV FULL_TIME
  • Founded in 2016, Assurance has worked to make buying insurance easier for everyone. Our team of humble collaborators is passionate and united in a common goal – protecting people and providing access ...
  • Just Posted

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Remote Medicare Benefits Consultant - License Required
  • Assurance
  • Nevada, NV FULL_TIME
  • Buying insurance can be complicated. Assurance is out to change that, leveraging data science to guide recommendations. Founded in 2016, Assurance has worked to make buying insurance easier for everyo...
  • Just Posted

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Director of Quality Assurance
  • AOI
  • SUMMARY Responsible for managing the Quality program of optical module manufacturing, including Quality Assurance, Quali...
  • 3/18/2024 12:00:00 AM

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Quality Assurance Director
  • The Judge Group
  • Hanover, PA
  • JDP is seeking a Director of Quality Assurance in Hanover, PA area! The candidate will be responsible for establishing a...
  • 3/18/2024 12:00:00 AM

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Director of Quality Assurance
  • Proclinical Staffing
  • Director of Quality Assurance - Permanent - Onsite Proclinical Staffing is seeking a Director of Quality Assurance to jo...
  • 3/18/2024 12:00:00 AM

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Director of Quality Assurance
  • Kelly Science, Engineering, Technology & Telecom
  • Kelly® Science & Clinical is seeking a Director of Quality Assurance for a direct hire opportunity with one of our clien...
  • 3/17/2024 12:00:00 AM

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Director, Software Quality Assurance
  • Universal Orlando
  • Orlando, FL
  • Universal Orlando Resort believes in-person collaboration is key to our success. Many of our Team Members work in a hybr...
  • 3/16/2024 12:00:00 AM

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Director of Quality Assurance
  • BrightHire Search Partners
  • We are seeking a Director of Quality Assurance to lead the quality systems for a revolutionizing medical device company ...
  • 3/16/2024 12:00:00 AM

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Director of Quality Assurance
  • Skills Alliance
  • I am working exclusively with a client looking to hire a Director QA to support their team. The successful candidate mus...
  • 3/14/2024 12:00:00 AM

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Quality Assurance Director
  • Conceal
  • Augusta, GA
  • Job Description Job Description As a Quality Assurance Director (QA Director), you will oversee the software quality con...
  • 3/14/2024 12:00:00 AM

Nevada is almost entirely within the Basin and Range Province, and is broken up by many north-south mountain ranges. Most of these ranges have endorheic valleys between them, which belies the image portrayed by the term Great Basin. Much of the northern part of the state is within the Great Basin, a mild desert that experiences hot temperatures in the summer and cold temperatures in the winter. Occasionally, moisture from the Arizona Monsoon will cause summer thunderstorms; Pacific storms may blanket the area with snow. The state's highest recorded temperature was 125 °F (52 °C) in Laughlin (e...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Software Quality Assurance Director jobs
$167,756 to $216,893

Software Quality Assurance Director in Lawrence, MA
A software quality assurance engineer is involved in tasks that include software design, writing source code, control of source code, reviewing code, configuration management, change management, program testing, integration of software, and release management process.
January 09, 2020
Software Quality Assurance Director in Atlantic City, NJ
It focuses on improving the process of development of software so that problems can be prevented before they become a major issue.
December 17, 2019
Software Quality Assurance Director in Lafayette, LA
Software quality assurance (SQA) is a means of monitoring the software engineering processes and methods used to ensure proper quality.
December 22, 2019