Computer Scientist / Engineer as Software Quality Engineer - Controls
Posted on Jan 20, 2019 by F. Hoffmann-La Roche AG
Switzerland, Aargau, Kaiseraugst FHLR
At Roche, we believe every employee makes a difference. We are passionate about transforming patients' lives. We are fearless in both decision and action; we believe that good business means a better world.
Are you searching for a new, meaningful opportunity, to develop your skills as a Software Quality Engineer? Then this position as an Engineer, with a positive mindset might be the right one for you!
Roche launched its NAVIFY brand demonstrating its dedication to provide healthcare professionals with digital decision support solutions that transform patient care. The existing portfolio will in the near future, evolve rapidly to include additional decision support applications and workflow products that address challenges faced by healthcare providers as well as research and development applications. Patient data security and privacy are of the highest priority for Roche.
In this context, Roche is building a very specialized team that builds and operates a cloud platform for its medical and clinical SaaS products. This team will be responsible for tackling the cybersecurity, compliance and development challenges of the healthcare industry while enabling high-velocity product development. The Quality Engineer will be an integral member of this team providing leadership for an innovative compliance strategy, test automation and alignment to design control processes that support state of the art software progress and operations.
We are looking for someone to run and update customer, product, and software requirements with various tools, e.g. ALM tools. You will collaborate across functions and departments (e.g. Legal, Engineering, Architecture, Product Management, PMO, Risk Management, Internal Audit, Quality, and Regulatory). Additionally, you will develop software QA metrics/KPIs, track and analyze to develop action plans. Further responsibilities: Guide the platform development and operations teams in design controls and risk management activities.
Understand business, technical, and operational requirements for Software as a Service and work with technical and product leaders to create plans consistent with quality and regulatory compliance. (QMS)
Apply modern DevOps principles to design quality and operations controls.
Drive automation of evidence creation, e.g. automated testing for unit tests, integration tests, and functional tests.
Author, review, and finalize Standard Operating Procedures (SOPs) verification and validation work including: Plan, Requirements, Test Plan, Protocols, Traceability Matrix, Reports.
Who you are You're someone who wants to influence your own development. You're looking for a challenge where you have the opportunity to pursue your interests beyond functions and geographies. Where your passion for technology and compliance will impact the lives of patients fighting cancer and many other disease areas in the future.
We need you as a highly motivated self-starter with curiosity that drives you. You embrace and value lean and agile principles to achieve positive outcomes. You are an extraordinary teammate with a common sense and a good communicator that gets to the point quickly.
You have a university degree (BS) or equivalent in computer science, engineering or another directly related discipline (CS, Eng, etc.). You have 5+ years of related experience.
Experience working in a multicultural environment and confirmed cultural awareness is an advantage. We search for someone with experience in the diagnostics, pharmaceutical or healthcare industry or other highly regulated industries like finance or insurance.
You are someone with a high attention to details. Additionally, you bring the ability to take ownership and be effective with limited supervision. Effectively you are engaging with team members in various functions and across different levels.
Strong organizational skills and ability to prioritize and evolve multiple activities simultaneously characterize you.
We need someone who is knowledgeable in Quality System Regulations, Medical Device Directive, ISO 13485 Quality Standards, and 21 CFR Part 11, 820. A deep understanding of HIPAA/HITRUST, ISO 27001, and GDPR are a strong plus, as well as CQE certifications.
Besides you know working in compliance with the Quality Management System(QMS) and Medical Device Product Development processes (PDP) for software, e.g., SaaS, SaMD, SiMD, etc. Furthermore, you bring:
Experience with SaaS and internet scale software development
Knowledge in creation and automation of software tests
Know-how in writing codes to test APIs and a confirmed understanding of microservices architecture.
Software validation specialist experience or software product test experience.
Excellent written and verbal communication skills; Ability to produce high-quality SOP's and product development plans, requirements and reports.
F. Hoffmann-La Roche AG
F. Hoffmann-La Roche AG