Senior Specialist I-Q&R QA/QE
Bangalore, Karnataka, India
3d ago

So, whatever your role, if you share our passion for helping others, you’ll be working towards creating a better and fairer future for all.

The Quality Engineer for Early Development is accountable for oversight of quality and risk management throughout the pre-productization development phase.

This role ensures that products / prototypes are developed in accordance with applicable standards & regulations to facilitate transfer into (clinical) studies or further development and commercialization.

In this role you will be responsible for supporting one or more Serviceability Portfolios for risk, ensuring key initiatives are executed and providing independent oversight to applicable design control elements

You are responsible for

Acts as single point of contact for R&D teams to ensure appropriate QMS processes are identified and implemented within the project, including identifying applicable deliverables and tailoring as appropriate

Identifies Quality / Regulatory requirements based on scope of development activities

Provide effective oversight of the execution of early design and risk management activities, including assisting teams in creation of Risk Management deliverables and reviewing or approving documentation

Executes Quality related problem-solving activities

Makes meaningful contributions to the team in combining the Agile methodology with the Quality System requirements

Ensures Quality is embedded within the organization by acting as a champion of best practices and by escalating quality related concerns

Collects and reports on Quality related key performance indicators when defined

Communicate with Q&R both within Research as well as in the business (where applicable) to align expectations and escalate when needed to the appropriate level in case non-compliances are not solved.

Provides guidance on key design inputs like usability, reliability, performance, supportability, manufacturability, localizability, safety, security, privacy, serviceability, sustainability and costs

Provides hands-on guidance in the creation of Design deliverables required by the Quality System

Act as a point of contact for multiple projects responsible to ensure that software design meets quality and compliance standards for every milestone

You are a part of

SSD Innovation Quality team that provides Quality engineering support for Services and Solution Delivery Innovation functions that focuses on serviceability engineering and provides SW solutions in the space of Serviceability Platform, Analytics Solutions Platform, Remote optimization and Service Solutions.

S&SD Innovation function develops 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.

S&SD Innovation functions work with BU R&D groups, Service Innovation groups, New Service Design, Professional Services, Philips Research, Field and Remote Service Engineers & Specialists to develop the right tools, applications and mechanisms for serviceability.

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

12+ years of Quality Engineering experience in a regulated environment preferably within the Medical Device space

Masters or Bachelor’s degree in Engineering or related field

Independently produces and guides others to complete Quality Engineering Documents. Can develop & administers quality related project plans and schedules.

Responsible for performing timely, quality engineering tasks like :

Produces and completes SW Quality Engineering documents under direct supervision.

May also provide other SW quality engineering support, including assisting organizational units in addressing SW Quality engineering deficiencies.

Assessing quality plans and product designs

Reviewing test and other performance data

Analyses of risk inputs and mitigations

Leading root cause analysis and quality problem solving.

Mentor other team members on quality related projects or issues.

Familiarity with software quality engineering principles

Good understanding of Medical device regulations and standards

Works on issues of diverse scope where analysis of situation or data requires evaluation of a variety of factors, including an understanding of current business trends.

Follows processes and operational policies in selecting methods and techniques for obtaining solutions.

Experience in early product development or pre-manufacturing activities

In return, we offer you

A meaningful career : your work will contribute to innovative health technologies and solutions that help improve billions of lives every year.

Health and well-being programs : to support you mentally and physically, allowing you to stay energized and be your best at work and beyond.

Career growth : access to a wide range of tools and resources to further your career, including a personal development budget, training, and coaching.

How we work at Philips

Our 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 everyone’s 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 isn’t 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.

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