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Senior Specialist

3 months ago

Bengaluru, Karnataka, India Philips Full time
JOB DESCRIPTION

Job Title

Senior Specialist - I - Q&R - QA/QE

Job Description

Job title: Senior Specialist - I - Q&R - QA/QE

In this role, you have the opportunity to

Establish, deploy and effective maintenance of QMS across the modality along-with training profiles are assigned and enforced.

You are responsible for

Ensure that appropriate SW Quality plans are designed that include all stages of the software lifecycle Validate key product design inputs like usability, reliability, performance, supportability, manufacturability, localizability, safety, security, privacy serviceability, sustainability and costs Provide effective oversight over the execution of the SW Quality Plan; which includes risk management activities and all design related activities during the software lifecycle Ensure software design quality and reliability targets are met for every project milestone Leading software quality related problem solving Using post-market data analysis to report on software performance in the market (provide feedback to manufacturing, suppliers or design teams) and initiate field actions when required Act as a single point of contact for project team Make substantial contribution to ways of working of combining Agile with medical software development

You are a part of

Quality and Regulatory department. As a member of this group you will be deploying the process and business requirements across the site.

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

Minimum years with an Engineering degree of any discipline Working experience in Software Engineering, Software Quality or Reliability Engineering Familiar with the medical or the aerospace industry Ability to define detailed software quality and reliability plans for new medical product developments to ensure those are safe, effective and reliable Ability to contribute to Risk Management and lead FMEA activities for new products and assurance that control measures are translated in appropriate critical requirements Strong exposure to application of Design Controls; ability to do thorough Design Reviews during new product development to ensure robust designs that further improve patient safety and product quality Ability to partner with V&V teams to assure thorough Verification, Validation and Usability testing Ability to lead reliability analysis to assess the risks associated with design concepts Experience with adequate and accurate review of DHF and DMR documents Understanding of global medical device regulations, requirements, and standards, such as 21CFR820, ISO13485, EU MDR, IEC 62366, IEC 62304 and ISO 14971 Experience with working in multidisciplinary teams in a high-tech R&D environment You continuously strive for excellence as a way of life and can inspire others to adopt this mentality of prioritizing quality above all else You are a self-starter who embraces the change

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:
There's a certain energy when everyone's in the same room that can heighten idea generation and creative friction needed for problem-solving.
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.
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.

Why should you join Philips?
Working at Philips is more than a job. It's a calling to create a healthier society through meaningful work, focused on innovative, customer-first health technology solutions. Help us improve the health and well-being of billions of people, every year. Ultimately creating a career that no one could have planned for. Even you.