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Job TitleQMS Engineer
Job Description
Job Title: QMS Engineer
You are responsible for:
Establishes, enforces, and oversees compliance for an effective Quality Management System (QMS) within the scope of activities, ensuring streamlined and efficient QMS structures and documentation across all levels of the Radiology Informatics Business Unit.
Manages the deployment of the QMS transition and ensures its effective implementation.
Plans and schedules audits, ensuring alignment with internal policies and external regulations.
Locally oversees the QMS components in scope, maintaining compliance and effectiveness throughout the transition duration.
Adds and manages local QMS documents in accordance with the evolving QMS.
Ensures training adherence and registration according to the QMS, generating training content for local QMS documents as needed.
Addresses issues of diverse scope, requiring analysis of various factors, including an understanding of business needs.
Advises the business on Quality Management System matters.
Leads and supports Document Control Specialists and Training Coordinators.
Serves as a Subject Matter Expert for Non-Product Software Validation (NPSS), Quality Management System (QMS), Document Control, Internal and External Audits, and Training.
Manages the Quality System Management Review process by collecting data, creating presentations, recording meeting minutes, and following up on action items.
Supports any other activities associated with QMS.
To succeed in this role, you should have the following skills and experience:
Bachelors degree in a scientific or technical field
Experience:
8-12 years overall experience
5+ years of experience in the medical device industry
Strong working knowledge of GMPs and other FDA regulations
Experience validating application activities.
Experience in corrective and preventive actions, including root cause analysis, documenting findings/actions, and implementing actions.
Experience with Software Medical Devices highly desire
Competency and Skills:
Solid Analytical skills - demonstrated ability to trouble-shoot complex process/system issues.
Strong IT skills, including MS Word (advanced user), Excel, Visio, and related MS Office applications.
Proven analytical capabilities.
Excellent communication, organizational and project management skill.
Excellent communication skills in English is a must.
In return, we offer you
At Philips, we are driven by our mission to improve the lives of 3 billion people per year by 2030, and every day we move closer to achieving our goal by creating cutting-edge solutions that lead to confident diagnosis, improved care, and increased quality of life for patients. Thanks to our employees who share our passion for improving lives, we are at the forefront of the Healthcare industry leading in image guided interventions, ultrasound, patient monitoring, cardiology informatics, sleep therapy, respiratory care and services.
How we work at PhilipsOur newly-adopted hybrid work concept fuses flexibility with collaboration to deliver great outcomes for our people and our customers. We are embracing an approach wherein we spend more time together than apart which for full-time employees translates to an average of at least 3 days working from the office and up to 2 days from home for our hybrid roles. Hybrid work flexibility means people can meet the changing demands of work and home in the most balanced, productive, and healthy way.
Our hybrid working model is defined in 3 ways:We believe in the importance of impactful collaboration: There's a certain energy when everyones in the same room that can heighten idea generation and creative friction needed for problem-solving.We embrace flexibility: Choosing where, when and how to work can vary according to task and team schedules. Flexibility isnt office or online, it means choosing the space that works best for you, your teams and our customers on a case-by-case basis.We want to be at our best: The way we work and our workspaces are designed to support our well-being, offer career advancement opportunities, and enable us to be at our best.
Why should you join Philips?Working at Philips is more than a job. Its a calling to create a healthier society through meaningful work, focused on innovative, customer-first health technology solutions. Help us improve the health and well-being of billions of people, every year. Ultimately creating a career that no one could have planned for. Even you.