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Posted: Sunday, August 6, 2017 6:15 AM

Software Quality Assurance Engineer Location: Bothell, WA Your challenge As the incumbent of this Quality & Regulatory (Q&R) role within Philips, your challenge will be to guide and support Business Groups, Markets and enabling functions to always do the right thing. This involves being a confident advisor on approval, regulatory compliance and quality management related topics, in order to achieve timely releases of innovative products that deliver high quality and outstanding reliability to the lives they will improve. The Quality Engineer for Software is accountable for oversight of quality plans, risk management, and compliance throughout the software lifecycle for mobile application software and firmware solutions. The Quality Engineer for Software independently audits the adequacy of design specifications, V&V test plans, reliability test plans, and Privacy and Security for software validation. This position also collects and analyzes data from performance in the field and evaluates it to drive SW improvements Responsibilities Working in the medical industry brings much fulfillment, as well as unique challenges. As part of our HealthTech – focused company, you will be responsible for successfully dealing with and managing Philips relationships with approval agencies such as the US Federal Drug Administration (FDA). Key areas of responsibilities (KARS) for this role include: Help define and establish internal process Way of Working on SW Scrum teams in accordance with SAFe, FDA, and IEC62304. Develops strategies and agreements for internal and external partnerships to define Roles & Responsibilities in support of QMS requirements. Establishes and drives quality and risk management plans. Ensures Adherence and Conformance of project teams to defined and agreed SW Quality/Development Plan and Risk Management activities during the software lifecycle. Initiates and ensures Risk Assessment discussion for proper SW classification along with Product Safety Assessment. Leads and Conducts regular stand-ups to review and drive Regulatory deliverables in accordance with applicable Medical Device SW standards. Ensures proper change control and requirements flow down in Agile SW development environment (Requirements to test cases). Ensures documentation processes (full traceability) of requirements per IEC62304 combined with TIR45. Ensures Privacy and Security Assessment activities are initiated in development and finalized before project launch, as well driving acceptance signoff by management. Validates key design inputs like: usability, reliability, performance, supportability, manufacturability, localizability, safety, security, privacy, serviceability, sustainability and costs Performs SW Quality engineering tasks like: Assessing SW Quality plans, assessing software designs, reviewing test and other performance data, analyzing market feedback, leading root cause analysis and SW Quality problem solving. Act as a single point of contact (person assigned to project team) responsible to ensure that software design quality related requirements/criteria are completed and meet SW Quality standards for every PRP milestone Use post-market analytics and statistics to report on software performance in the field (provide feedback to manufacturing, suppliers or design teams) and initiate field actions when required Follows processes and operational policies in selecting methods and techniques for obtaining solutions. Able to understand technical software development methodologies (e.g. Agile SAFE) and tailor/adapt for compliance to ISO and FDA compliant quality systems. Works on issues of diverse scope where analysis of situation or data requires evaluation of a variety of factors, including an understanding of current business trends. Your team As a result of Philips renewed commitment to Quality, it has recently restructured its organization to ensure you and your department have clear interfaces with Philips Business Group and Market leadership, and can harness the expertise of five Centers of Excellence (COEs). These 5 COEs specialize in the following capabilities: Regulatory & Clinical Affairs, Supplier Quality, Quality Management System, Quality Assurance & Engineering, and Compliance & Audit. As part of this new structure, you are empowered to use your voice and expertise to have a positive impact on your team, our business, and health technologies that will improve the health, well-being and care for people around world. Philips Oral Healthcare creates meaningful innovations that improve people's lives; our Sonicare and Discus products help provide better health and more beautiful smiles across the globe We are looking for A person who is excited by the unique professional challenges that our Quality Transformation presents, has strong technical competencies, and demonstrates resilience challenging, often demanding situations. We are looking for a perfectionist- a fixer who continuously strives for excellence as a way of life; not just as a job. We’re looking for someone who can inspire others to adopt this mentality of prioritizing quality above all else in a relentless pursuit to improve the quality of life billions for the billions of people Philips brand touches each year. Specific skill requirements for this role include: Bachelor’s Engineering, SW degree, or equivalent technical degree. 5+ years of related experience in a medical device other regulated industry. Working knowledge of appropriate global regulations, requirements, and standards (e.g 21CFR820, ISO 13485, IEC 62304, ISO 14971) Working knowledge of Agile and traditional (Waterfall) software development methodologies Working knowledge of system software, firmware, and mobile app (iOS and Android) development QA Certified Software Quality Engineer (CSQE) preferred Experience leading change in dynamic, fast paced environment Our offer This role comes with a competitive compensation offering and a generous holiday / vacation offering, but that’s not all. Quality is right on the top of Philips leadership agenda and that means you have the unique opportunity to come in and have a recognized voice to drive and witness exciting, transformational changes. You will be empowered to drive high quality, ground breaking innovations with a globally recognized, premium brand behind you. And when you are successful in this role’s mission, you will have an array of diverse career options open to you – across different functional areas, product lines, business groups and/or geographies. That is a commitment Philips Quality Leadership team has made and stands by. Advance your career in an environment that supports work-life balance, health & well-being and continuous learning. Making a difference begins right here, where you come first. Ready to start improving lives by putting your personal skills & passions to work? Apply Today! Find out more info about Philips at www.philips.com/na/careers Philips is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex (including pregnancy), sexual orientation, gender identity, national origin, genetic information, creed, citizenship, disability, and protected veteran or marital status. #LI-JJ1

Click here for more info: https://philips.taleo.net/careersection/jobdetail.ftl?job=213070&lang=en


• Location: Bothell, Seattle

• Post ID: 30932173 seattle
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