Software Quality Engineer
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Software Quality Engineer
Ref No.: 18-29938
Location: Northridge, California
Start Date / End Date: 05/14/2018 to 04/30/2019
Company: Artech Information Systems
Job Title: Software Quality Engineer
Location: Northridge, CA
Duration: 12 months
Job ID: 18-29938
 
Basic Qualifications:
  • Bachelor’s Degree in Engineering.
  • 5+ years’ experience with software development or software quality assurance (with Bachelor’s Degree) or 3+ years’ experience (with Master’s Degree).
  • Experience working in a regulated industry (e.g., FDA-regulated).
  • Strong familiarity with regulatory requirements ISO 13485, 21CFR 820, ISO 14971, and IEC 62304.
  • Strong Project Management skills in leading Software quality assurance activities.
  • Hands on knowledge of design controls and risk management (system risk analysis and Software FMEA)
  • Strong working knowledge of quality systems and quality assurance processes and principles, with a focus on software development and software quality assurance activities.
 
Position Responsibilities:
  • Providing PDP and design control expertise for and execution of different BU projects, such as:
  • Collaborating with project / program teams to ensure work products comply with Healthcare procedures, acceptable qualitative and quantitative criteria, and global standards, regulations, and guidance.
  • Generating and driving risk management activities including system risk analysis, DFMEA, PFMEA, SFMEA and requirements compliance matrix (ERM).
  • Reviewing of all project / program work products (e.g. plans, requirements, specifications, tests, test results, traceability, design reviews, reports, etc.).
  • Participating in code reviews and be able to read code.
  • Planning and reviewing validation plans for new product development in conjunction with R& D, Process Engineering, Manufacturing, Supplier Quality Assurance, Regulatory Affairs, Marketing and other service groups.
  • Assisting Supplier Quality Assurance with supplier audits; interfaces with Purchasing and Supplier Quality Assurance with supplier issues.
  • Chair cross-functional change control boards.
  • Utilizes knowledge of various Software Development Lifecycles (SDLC).
  • Training and coaching cross-functional peers on maintaining compliance to internal and external Quality requirements and regulations in support of the deployment of the different BU strategies and products.
  • Driving clarity and consistency in documentation.
  • Leading CAPA projects and assisting post market analysis.
  • Participating in support of external regulatory audits and inspections.
  • Driving Process improvement activities.
  • Work under consultative direction toward predetermined long-range goals and objectives. Assignments are often self-initiated. Determine and pursue courses of action necessary to obtain desired results through consultation and agreement with others rather than by formal review of superior.
  • Performs other related duties as assigned.
 
Desired/ Preferred Qualifications:
  • Master’s Degree in Engineering, Quality, Regulatory, or related.
  • ASQ Certification in Quality or Reliability.
  • Working knowledge of IEC 60601-1 and MDD.
  • Strong oral/ written communication skills and interpersonal skills.
  • Working knowledge of software development for medical devices.
  • Working experience with Mobile Apps (iOS/Android) and/or PC/Web based product software.
  • Ability to author technical reports, business correspondence and standard operating procedures.
  • Ability to apply knowledge and work with development and supply vendors to ensure compliance to Healthcare requirements.
  • Working experience in a global environment spanning multiple sites and systems; ability to navigate and constructively influence across groups.
  • Ability to represent the department in frequent inter-organizational and outside vendor contacts.
  • Ability to work effectively within a team in a fast-paced, ever-changing environment.
  • Strong verbal and written English communication skills with an ability to effectively communicate at multiple hierarchal levels in the organization.
  • Ability to multi-tasks, prioritize, meets/exceed deadlines and hold themselves, and others accountable.
  • Experience with leading and executing multiple projects in parallel, including large and complex projects.
  • Self-Starter with a sharp focus on quality and customer experience.
 
Thanks
Rajiv Maruthi
Rajiv.maruthi@artech.com