Quality & Safety
Secondment via YER
Medical & Health
Over deze vacature
In this role, you have the opportunity to ...
Ensure process compliance to regulations, and that optimization and efficiency are built into the Management System and Quality Management System (MS/QMS) processes across all sectors and groups in partnership with the other business functions. Provide quality and regulatory support to End to End (E2E) Program teams to ensure Philips Excellence Process Framework (PEPF) and Philips Integrated Landscape (PIL) deployments are completed and maintain compliance of the QMS during the transition period.
You are responsible for
The Compliance Domain subject matter expert is responsible for performing activities to ensure that the obligations of the Quality & Regulatory (Q&R) compliance domain are addressed. Responsibilities include keeping oversight of deployment projects and ensure E2E process content, validated software applications and QMS deployment deliverables will be available per the agreed schedule.
• Responsible for establishing an effective compliance framework in the Q&R domain and the adherence to it.
• Responsible for embedding Q&R Compliance deliverables in project plans.
• Coaches Business, Market and Function MS/QMS and Q&R teams on the deployment aspects of E2E Projects and creation of Local QMS Transition Plans
• Acts as the gate keeper for deployment of PEPF processes by measuring deployment readiness of PEPF processes.
• Provide visibility on PEPF QMS Deployment statuses and Project Deployment Readiness.
• Defines and recommends remediation and/or improvements actions.
• Maintain the compliance catalogue for the Q&R domain, including the development and maintenance of Philips (multi-domain) compliance standards, Philips (multidomain) compliance requirements and Philips (multidomain) compliance controls.
With a growing presence in cardiology, oncology, and women's health, Philips operates in the areas of Imaging Systems, Patient Care & Clinical Informatics, Home Healthcare and Customer Services. Philips combines its clinical expertise and human insights to create innovative solutions across the continuum of care, in partnership with clinicians and our customers, to provide better value and expand access to care for millions. Our teams are working hard every day to improve patient outcomes all the way from disease prevention and screening to diagnosis, treatment, therapy monitoring, and disease management. Irrespective of whether the care cycle takes the patient from doctor's office to hospital or hospital to home, or simply from one medical department to another, Philips Healthcare's unique medical solutions are designed to optimize the quality and flow of patient information and clinical decision making.
You will be seconded via YER to Philips.
To succeed in this role, you should have the following skills and experience:
- Bachelors degree, preferably in a scientific discipline.
- Minimum of 7 years of experience working in Quality Assurance / Quality Engineering / Quality Systems supporting multiple functional disciplines within a global medical device industry.
- Expert in the understanding of applicable international and national laws, regulations, and standards relevant to their domain. Ability to translate same to Philips responses, initiatives, and actions.
- Proven experience in Quality Management System processes, including cross-sector or business process standardization, ensuring effectiveness and efficiency while maintaining compliance with worldwide regulations.
- A comprehensive understanding of the diverse worldwide medical device quality regulations, including areas of device design, development, manufacture, distribution, worldwide device marketing, sales, service, complaint handling, and post-market surveillance.
- An ability to successfully communicate and educate Quality Management System regulations, policies, and strategies to teams at all levels of the organization.
- Foundational database knowledge (structure of database object and models).
- Proven advanced skillset and enterprise experience MS Excel and MS Access.
- This position requires extensive knowledge of FDA QSRs, ISO 13485, JPAL, China GMPs, and other worldwide Quality System Regulations.
- Ability to operate efficiently and effectively in a fast-paced environment.
- Fluent in both written and verbal English.