Oferta pracy

IT Validation Engineer (Quality function)

Ascensia Diabetes Care Sp. z o.o.

  • Warszawa

    Warszawa, Masovian
  • offer expired a month ago
  • contract of employment
  • full-time
  • senior specialist (Senior), expert
  • hybrid work
  • remote recruitment

Your responsibilities

  • Serve as IT project Quality team member as requested in support of business application (IT) and IT infrastructure projects. Train and advise IT project teams on required activities, deliverables, and dependencies to achieve project goals in full compliance with company validation procedures.

  • Work with business users across departments to evaluate new IT business solutions to establish to what extent, if any, those applications, cloud systems, or infrastructure systems include Quality data, records, or transactions.

  • Develop project plans including, but not limited to, Quality plans, Validation Plans, and Data Migration Plans. Provide expertise to the IT project team regarding organizational process implementation on the project. Answer questions about software and system development life cycle processes and process compliance issues throughout the project lifecycle.

  • Interface with supplier and customer Quality personnel on projects to coordinate software regulatory and development processes and deliverables.

  • Drive formal document peer reviews for project deliverables to minimize documentation defects and set a high bar for documentation quality.

  • Serve as software/hardware/cloud Subject Matter Expert support on evaluations and audits of suppliers of business software. Prepare supplier software evaluation reports, gap analyses, and risk management plans to ensure that key software suppliers plan and deliver appropriate software and documentation.

  • Support continuous efforts to improve the organizational software quality system to ensure regulatory compliance, audit readiness and to assure state-of-the-art software development methods.

Our requirements

  • Experience in business applications for a medical device or other life science company including, but not limited to, software validation requirements for FDA 21 CFR 820, 21 CFR Part 11, ISO 13485, GAMP 5, and AAMI TIR 36.

  • Experience in Computer Systems Validation

  • Must be able to “break down” technical IT concepts to engage business users in proactively supporting IT solutions.

Optional

  • Experience with qualification of on-premise and software-as-a-service IT hardware and infrastructure is preferred.

  • Application of Six Sigma or Lean methods to support process flow optimization prior to proposal of new business technologies

  • Experience in a software development environment, with technical software engineering experience (design, coding, testing)

What we offer

  • Contract of employment

  • Annual bonus

  • Private medical care – extended package

  • Life insurance

  • Pension Plan

  • Lunch Card 190 PLN/month

  • Multicafeteria: Sport Card, Cinema tickets etc.

  • Employee Assistance Program

  • Access to LinkedIn Learning

  • Language classes online

  • Benefits

  • sharing the costs of sports activities

  • private medical care

  • life insurance

  • meal passes

  • sharing the costs of tickets to the movies, theater

  • language classes online

Currently, we are looking for an experienced Master Data Management professional to lead master data and business process integration activities focusing on product, customer, pricing and vendor master data. The individual will work in close partnership with cross-functional teams across the organization to provide thought leadership in overall master data management principles, best practices and technologies.

Ascensia Diabetes Care Sp. z o.o.

Ascensia Diabetes Care is a global specialist diabetes care company, dedicated to helping people living with diabetes. Our mission is to empower people living with diabetes through innovative solutions that simplify and improve their lives. We use our innovation and specialist expertise in diabetes to develop high quality solutions and tools that make a positive, daily difference for people with diabetes.

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