QMS Software Validation Engineer

Company: Philips
Location: Cambridge
Posted on: January 13, 2022

Job Description:

Job TitleQMS Software Validation EngineerJob DescriptionIf you are a Colorado resident and this role is a field-based or remote role, you may be eligible to receive additional information about the compensation and benefits for this role, which we will provide upon request. You may contact 888-367-7223, option 5, for assistance.In this role, you have the opportunity toLead and manage NPSS projects for Hospital Patient Monitoring while ensuring the accuracy, completeness, and compliance of software applications that automate Quality System processes. This position will work within a global organization to complete projects and resolve challenges related to NPSS projects and deliverables.You are responsible for

• Executes and manages software validation and control activities by authoring, reviews, and or approving software validation deliverables for non-product software systems, including but not limited to software validation plans, requirement test plans/protocols/results, risk assessments, traceability matrices, and summary reports.
• Monitor software validation deliverables and activities for assigned NPSS (Non-product Software Systems) applications to ensure that regulations, protocols, procedures, and methodologies are followed and that appropriate and complete documentation is captured and reported to support validation activities.
• Ensures the accuracy, completeness and compliance of SW validation deliverables
• Provide quality assurance oversight, guidance, support, and interpretation, emphasizing software validation to personnel in their validation efforts to ensure compliance; recommend appropriate corrective actions where needed.
• Ensure that new software and changes to existing software or infrastructures are validated before approval and use by application of controls and risk management in reviewing and approving change-control requests to assess potential quality system impact.
• Define and establish lean practice, including but not limited to tools, methods, standards, competency, process and process performance for software validation, and lifecycle control of new and existing software systems.
• Maintain communication with the team to ensure understanding of schedule commitments, actual schedule durations, anticipated scope changes, and project risks associated with validation activities.
• Responsible for applying specialized and multi-functional skills, developing considerable on-the-job experience, using a wide-range of experience, professional concepts, and detailed understanding of company policies and procedures to resolve complex issues in creative and effective ways.
• Provides guidance and feedback for applicable regulatory requirements and Philips policies and procedures.
• Support external regulatory assessments and internal audits by providing validation documents and subject matter expertise
• Support management and standardization of QMS processes in scope to ensure effective and compliant QMS.
• Support deployment of Non Product System Software Validation process in the local Quality Management System, ensuring local and cross business harmonization, standardization and regulatory compliance
• Business process expert for processes in scope, acting in support of the local business QMS lead and QMS element owners across the business to deploy harmonized and standardized Philips processesYou are a part of:As a result of Philips renewed commitment to Quality, it has recently restructured its organization to ensure you and your department have clear works 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.To succeed in this role, you should have the following skills and experience
  • Bachelor's degree in engineering or IT-related fields, preferably with an advanced degree in Quality, Regulatory and Software Engineering.
  • 5+ years of consistent experience in IT Software Validation methodology in regulated medical device, pharmaceutical and healthcare industry.
  • 5+ years of experience with IT software applications development and using established Computer System Validation (CSV) methodology such as GAMP 5 and FDA guidelines.
  • Expertise in validation of enterprise wide quality IT systems using established Computer System Validation (CSV) methodology such as GAMP 5 and FDA guidelines.
  • Experience working in a disciplined regulated industry in the application of automated technology, particularly 21 CFR including part 11, ISO 13485, and EU MDR.
  • Ability to apply current inspectional techniques to project documentation during the system lifecycle and prior to FDA inspection to ensure a comprehensive documentation package is created and maintained.
  • An ability to successfully communicate and educate Quality Management System regulations, policies and strategies to teams
  • Experience with deployment of Quality Management System processes as identified
  • Excellent communication, organizational, and project management skills.
  • Competency in project management and the execution of multiple projects.
  • Successful experience working with cross-functional teams across multiple work locations.
  • Network-oriented and able to interact with different business functions and can work within numerous systems.
  • Quality Business Partner experienced with planning, communication, presentation skills, and people managementIn return, we offer you
    A path towards your most rewarding career. Philips is growing its marketing capability enterprise wide. Succeeding in this global role in a complex environment will open many doors for your long term career, in other areas in Philips or otherwise. We also believe that we are at our best as a company when you are at yours as a person. Thus, we offer competitive health benefits, a flexible work schedule and access to local well-being focused activities. Furthermore, Philips University is available to all employees for learning and development opportunities.Why should you join Philips?Working at Philips is more than a job. It's a calling to create a healthier society through meaningful work, focused on improving 3 billion lives a year by delivering innovative solutions across the health continuum. Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways. Learn more by watching this video.To find out more about what it's like working for Philips at a personal level, visit the Working at Philips page on our career website, where you can read stories from our employee blog. Once there, you can also learn about our recruitment process, or find answers to some of the frequently asked questions.It is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without regard to race, color, ethnicity, religion, gender, pregnancy/childbirth, age, national origin, sexual orientation, gender identity or expression, disability or perceived disability, genetic information, citizenship, veteran or military status or a person's relationship or association with a protected veteran, including spouses and other family members, marital or domestic partner status, or any other category protected by federal, state and/or local laws.As an equal opportunity employer, Philips is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance.Equal Employment and Opportunity Employer/Disabled/Veteran

Keywords: Philips, Cambridge , QMS Software Validation Engineer, IT / Software / Systems , Cambridge, Massachusetts