Quality and Regulatory, EMR
Philips HealthTech – Bangalore India
The primary purpose of this position is to function in the role of Specialist- I QA/QE in Q&R function for the Electronic Medical Record (EMR) business. This role will support the realization and delivery of various products, key business improvement programs, and work with cross functional teams from various geographical sites from South America . The key challenge is to contribute to the success of Philips Health Systems by managing Q&R challenges on both process and product level. The key to succeed is to utilize all your technical and personal skills in the dynamic, multi-disciplinary environment
Electronic Medical Record (EMR) is one venture under Connected Care Business Cluster created to provide our global customers with integrated innovative solutions to manage data across the hospital/clinic networks, by digitalizing clinical pathways and, thus, enabling seamless communication of relevant data across the health continuum. In the past years we have collectively developed and delivered a winning Electronic Medical Records (EMR)/Electronic Health Records (EHR) solution, commercially known as TASY, serving as our springboards for the future. TASY is a complete, integrated EMR solution for the management of private and public healthcare organizations .
EMR BIU has employees dispersed in two main locations i.e Blumenau (Brazil), and Bangalore (India). Being a global organization, almost all EMR activities take place in more than these two sites, as we have strong footprint in the targeted markets where the solutions are co-designed and implemented at the customer sites, such as Mexico, Germany, and Middle East as of now
The Quality & Regulatory group is responsible for:
Quality assurance and Quality Engineering aspects of product development
Assessment of the quality performances and compliance of the organization
The relation with external regulatory bodies
Supporting the continuous improvement of processes and the initiation, maintenance and certification of the Quality Management System (QMS), while assuring regulatory compliance of this QMS.
You are used to working in an independent fashion to deliver very demanding assignments to successful completion. You are not afraid to embrace change and act as a change agent to transform organizations and teams in to highly performing units using best practice processes. In past roles, you have used a data driven approach to work objectively across multiple business functions, managing business improvement or change management projects. You have a demonstrable track record in working with senior executives who have sponsored your projects, all the way down to individual contributors who deliver software and services as part of your end project deliverables. You enjoy the challenge of managing through influence across a matrix organization, and have found ways to be successful while operating under budget and other organizational constraints.
Perform a wide variety of activities pertaining to compliance with applicable regulatory requirements, quality management system (QMS) maintenance, improvement and harmonization, and quality control and assurance.
Verification of execution of processes and their deliverables in product creation and subcontracting projects and report the findings to upper management.
Review and Approval of designated project documentation in product creation projects.
Advice to product creation projects concerning the definition and implementation of quality assurance activities
Advise upper management with respect to release for delivery of products
Support and represent Q&R discipline in Design Reviews, Hazard Analysis brainstorms, Health Risk Assessments
Initiate, stimulate, and support the implementation of process improvements
Execution of audits in all business processes and report the findings to upper management
Support and advise the organization in corrective and preventive actions
Participate in the maintenance, improvement and deployment of the Quality Management System
Translates regulations and standards and bring them to consolidation in the organization and the Quality Management System
Represent the approbation officer in projects and support in the activities to acquire product licenses and approvals
Participation in and verification off changes to DMR and release orders where Q&R involvement is needed.
Qualifications and Know-How:
Bachelor or Master degree in relevant knowledge domain, e.g.: Computer Science , electronics, Electrical or information technology.
Around 6 to 8 Years of Professional Experience , with 2 to 3 Years in medical device domain
Knowledge of relevant external standards for Quality Management Systems for medical devices (e.g. ISO13485, ISO 14971, MDD, FDA-QSR)
Knowledge of (software) processes and procedures
Qualified Auditor of Quality Systems ( Preferable)
Good skills in reporting, both in writing and oral
Fluent speaker and writer in English
Project management knowledge and skills.
Knowledge of product creation and (software) development methods & tools
Experience in using problem solving tools
Experience in working with legal documents ( Preferable)
Knowledge of external regulations and standards relevant for our products ( Preferable)
Knowledge on Product Quality Engineering , metrics and KPI’s