Senior Software Quality Assurance Engineer

2 weeks ago

Irving, Texas, United States LanceSoft, Inc. Full time

Position: Senior Software Quality Assurance Engineer

Company: LanceSoft, Inc.

Job Overview:

  • This role involves providing quality assurance support for the development of new medical technology products, encompassing tasks related to the software development lifecycle (SDLC).
  • The primary responsibility includes reviewing and engaging in all phases of product design control for both existing and in-development projects. A solid grasp of the software development lifecycle (SDLC) is essential, along with a comprehensive understanding of design controls, which include design input, risk management, design verification, design validation, and design output/transfer processes and tools as they pertain to software product development.
  • Efficiently navigating and facilitating these processes is crucial to ensure that product teams deliver safe and effective solutions.

Key Responsibilities:

  • Implementing and upholding the quality system's effectiveness.
  • Design/Change Control - Responsibilities include participating in the creation and review of all design inputs, risk management strategies, design verification, design validation, and design output/transfer related design change activities.
  • Risk Management – Applies fundamental Risk Management principles and contributes to the development and/or revision of Risk Management Files, FMEAs, etc.
  • Design Verification/Validation – Understands and applies basic Design Verification/Validation methodologies. Engages in the development, modification, and design review of protocols, data summaries, and records.
  • Complaint/Defect Analysis - Investigates complex complaints and/or defects under management supervision, providing compliant solutions to various intricate issues. Ensures proper documentation related to responsibilities.
  • Documentation - Reviews documentation for precision, clarity, consistency, completeness, and compliance across projects of varying complexity. Plans and executes assignments with a broad range of difficulty.
  • Quality System Compliance - Maintains awareness of industry regulations. Ensures adherence to site-level policies and procedures by promptly reporting non-compliance issues to management as appropriate. Remains vigilant to ensure compliance with Quality Policy and Quality system procedures.
  • Quality Engineering – Collaborates on project teams and technical review boards. Coordinates quality decisions among different quality and engineering groups, effectively guiding project teams through our processes and procedures to ensure the delivery of safe and effective products.

Accountability and Scope:

  • Ability to thrive in a dynamic and fast-paced environment.
  • Capable of managing multiple projects simultaneously.
  • Strong communication skills with peers, team members, and management.
  • Anticipates the impact and risks associated with decisions and actions at both project and organizational levels.
  • Understands the implications of proposed changes and project demands on both internal and external stakeholders.

Minimum Qualifications:

  • Bachelor's degree in Computer Science, Software Engineering, Biomedical Engineering, Life Science, or a closely related field, or a relevant combination of education and experience.
  • Master's degree preferred. A minimum of 4 years of experience covering the entire software lifecycle and design control processes in a collaborative environment.

Preferred Qualifications:

  • Experience with tools such as HP Quality Center, Serena Business Manager, Siemens Teamcenter Product Data Management, and IBM DOORS is preferred.
  • Familiarity with FDA regulations, Quality System Regulations (QSR), Medical Device Directive, ISO guidelines, and 21 CFR Part 11.
  • Experience in software testing practices, methodologies, and techniques, particularly in the context of medical devices, is advantageous.

Employee Benefits:

LanceSoft offers a comprehensive benefits package for full-time regular employees working a minimum of 30 hours per week, including:

  • Multiple options for Medical Insurance
  • Dental and Vision Insurance
  • 401k Contributions
  • Critical Illness Insurance
  • Voluntary Permanent Life Insurance
  • Accident Insurance
  • Additional Employee Perks

About LanceSoft:

LanceSoft is recognized as one of the largest staffing firms in the United States. Our mission is to foster global cross-cultural human connections that enhance the careers of our employees and strengthen the businesses of our clients. We leverage our extensive global network to connect businesses with the right talent and individuals with the right opportunities, all while maintaining an unbiased approach.

EEO Employer:

LanceSoft is a certified Minority Business Enterprise (MBE) and an equal opportunity employer. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.

  • This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. LanceSoft makes hiring decisions based solely on qualifications, merit, and business needs.

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