Job TitleSpecialist I - Q&R -QA/QE, HI Q&R Process QA &QE
Quality and Regulatory, Philips I2M Services
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 Philips I2M Services 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. 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
Serviceability R&D focuses on serviceability engineering and provides SW solutions in the space of Serviceability Platform, Analytics Solutions Platform and Remote optimization.
We develop software to install, diagnose, service and monitor medical devices. We also offer tools and methods for the creation and sharing of device diagnostic knowledge using latest technologies.
We work with BIU R&D groups, Service Innovation groups, Philips Research, Field and Remote Service Engineers & Specialists to develop the right tools, applications and mechanisms for serviceability.
Join this dynamic and an energetic Serviceability R&D team to be part of this exciting journey in building platforms, solutions and services through cutting edge technologies, which would enable to save service costs through ETTR reduction by enabling faster diagnosis of issues and create new tools and service for generating new revenue streams.
The Quality & Regulatory group is responsible for:
- Quality assurance and Quality Engineering aspects of product development, Solutions and Services
- 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.
The Quality Engineer for Software is accountable for oversight of quality and risk management throughout the software lifecycle. The Quality Engineer for Software independently audits the adequacy of design specifications, V&V test plans, and reliability test plans for software validation. This position also collects and analyzes data from performance in the field and evaluates it against reliability specifications for software.
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
- 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
- Ensures that appropriate SW Quality plans are made that include all stages of the software life cycle and supports SW Quality Plan design
- Validates key design inputs like: usability, reliability, performance, supportability, manufacturability, localizability, safety, security, privacy, serviceability, sustainability and costs
- Provides effective oversight of: the execution of the SW Quality Plan and any Risk Management activities, and of all design related activities during the software lifecycle
- Can lead quality related problem solving for software
- Act as a single point of contact (person assigned to project team) responsible to ensure that software design quality related requirements/criteria are completed and meet SW Quality standards for every PRP milestone
- Make a substantial contribution to ways of combining Agile with medical software development
- Support and facilitate the department in enabling and assuring that products are developed and produced in compliance with requirements from applicable standards
Qualifications and Know-How:
- Bachelor or Master degree in relevant knowledge domain, e.g.: Computer Science, electronics, Electrical or Information technology.
- 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.
- Sound knowledge of the basic functionality of our products
- Knowledge of product creation and (software) development methods & tools
- Experience in using problem solving tools
- Experience in working with legal documents
- Knowledge of external regulations and standards relevant for our products
- Ability to translate legal requirements in to procedures and instructions
- Total experience of 8 to 10 years with at least 2 years of experience with medical Device Domain
If you forgot your password, you can click the Forgot Password button on the Sign In screen to reset it.
If you have any other questions regarding the recruitment process please refer to our FAQs. In case of technical difficulties with the website, please send an email to firstname.lastname@example.org.
(Note: To ensure fairness and legal compliance in our recruitment processes, only technical issues will be monitored through the above inbox. Please do not submit resumes or applications to this email, as they will not be reviewed. Only applications received through the online application process will be considered.)
Philips is a world leading health technology company with a vision to make life better for people worldwide through meaningful innovation. Making good on this promise depends on our inclusive, passionate, inspirational, collaborative and diverse team.