Compliance Domain subject matter expert (Freelance)

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 maintaining 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.
   

You are a part of
The team Global Quality MS-QMS Transformation, which provides MS/QMS support to business, markets, and functions with respect to the implementation of Philips Quality Management Systems and management system. The Compliance Domain subject matter expert participates directly in the Philips E2E programs to support our organizations to achieve the consolidation and standardization objectives through deployment of PEPF processes and PIL tools.

To succeed in this role, you should have the following skills and experience

• Bachelor's 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 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, an extensive knowledge of FDA QSR's, ISO 13485, JPAL, China GMP's and other worldwide Quality System Regulations.
• Ability to operate efficiently and effectively in a fast-paced environment
• Fluent in both written and verbal English