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Philips QMS Software Validation Engineering Manager in United States of America - Home Based, Massachusetts

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If 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 to

Lead and manage the NPSS team and projects to achieve global goals and deliver on KPIs while ensuring the accuracy, completeness, and compliance of software applications that automate Quality System processes.

You are responsible for

  • Assure software validation policies and procedures are implemented from planning to retirement across all automated processes that drive, interface with, and provide data for the Quality System.

  • Provide direction on compliance and control on cross-functional programs in support of software validation and lifecycle requirements activities.

  • 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.

  • Provides guidance and feedback for applicable regulatory requirements and Philips policies and procedures.

  • Manage the implementation of the Business' long-range strategic transformation initiatives across the BG.

  • Essential contact/resource for functions E2E, ensuring positive and collaborative relationships with our business partners.

  • Coordination with business stakeholders; communication, promotion, and management of strategic changes.

  • Support external regulatory assessments and internal audits by providing validation documentation and subject matter expertise and interacting with external regulatory agencies and senior management on matters concerning compliance responsibilities and risk.

  • 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.

  • Implement practices around software control for all non-product software systems in line with applicable policies and procedures.

  • 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.

  • Facilitate the application of controls and risk management by reviewing and approving change-control requests to assess potential quality system impact.

  • Contribute software validation and lifecycle control learnings and best practices to advance departmental methods and execution.

  • 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.

  • Implements strategic policies when selecting methods, techniques, and evaluation criteria for obtaining results.

  • Establishes and assures adherence to budgets, schedules, work plans, and performance requirements.

  • Works on issues where analysis of situations or data requires an in-depth knowledge of organizational objectives while receiving little instruction on day-to-day work and general instruction on new assignments.

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.

  • Minimum 7 years of experience in validation of computer systems and systems security and control.

  • Experience managing a team directly or indirectly to deliver business application implementation projects, including experience as an active contributor on projects with expected deliverables and responsibility for delivering organizational objectives.

  • Experience working in a disciplined regulated industry in the application of automated technology, particularly 21 CFR including part 11, ISO 13485, and EU MDR.

  • Experience implementing computerized systems comprised of multiple application types in a regulated environment.

  • Demonstrated ability to interact and communicate (both oral and written) with junior project team/organizational members, business leaders, and senior executives.

  • Expert understanding of current inspectional practices of FDA notified bodies and other regulatory agencies, including the previous interface with such bodies during regulatory assessments or inspections.

  • 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.

  • Demonstrated ability to effectively use critical thinking and logic to solve problems and make decisions.

  • Solid Analytical skills - demonstrated ability to troubleshoot complex process/system issues.

  • Effective judgment and decision-making skills under stressful situations.

  • 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 management.

  • Demonstrated capability in critical thinking and leadership with strong abilities in relationship management.

  • Ability and willingness to travel 20% domestic and international.

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.

To find out more about what it’s like working for Philips at a personal level, visit the Working at Philips pageon 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.

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