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Philips Product Quality Engineer India, Karnataka 787934800
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You are responsible for
Independent oversight of the design input process, design V&V activities, design transfer and product realization, and performance in the field to ensure that all design requirements are effectively considered.
Providing analytics to the Business on the efficacy and efficiency of the design and product realization processes
Performing independent technical assessment on product quality performance and post‐market product quality analysis.
Leading quality related problem solving and root cause analysis during design and manufacturing.
Acting as a single point of contact (person assigned to project team) responsible to ensure that hardware design meets quality and compliance standards for every milestone.
To succeed in this role, you should have the following skills and experience.
Bachelor’s/Master’s Degree in a science or engineering discipline
6-8 years of overall experience
2+ years of experience in the product design as demonstrated by a role in quality, engineering, service, or manufacturing in a regulated environment.
Preferably Medical Device experience.
Knowledge of the Complaints and Post-Market Surveillance connections with Product Safety Risk Management
Ability to lead a cross-functional team within a business, following standard processes, to help improve patient safety in our products.
Ability to be a self‐starter, enthusiastic and strategic thinker with a drive for quality.
Excellent negotiating skills
Familiarity with:
EN ISO 13485:2016
MDR (EU)2017/745
MDD (93/42/EEC)
MDSAP
IEC 62304 Medical Device Software Life Cycle Processes
IEC 14971 Risk Management to Medical Devices
ASQ Quality Engineer certification is an advantage.
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.
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