Philips Mechanical Designer - QPL 

India, Maharashtra 

715858884

Mechanical Designer - QPL

Mechanical Designer - QPL (Quality Project Lead)

Job Description :

In this role,

The Quality Engineer is accountable for quality oversight of system, hardware and risk management throughout the product life cycle. The Quality Engineer provides 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 met. The Quality Engineer also provides analytics to the Business on the efficacy and efficiency of the design and product realization processes

• Ensures that appropriate quality, reliability- and Post Market Surveillance (PMS) plans are made and include all stages of the product life cycle Supports Quality Plan design for hardware and Software design and ensure they meet quality and compliance standards for every planned milestone.
• 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 quality, reliability, PMS Plans, any Risk Management activities, and all of design related activities during the product/system lifecycle
• Performs independent technical assessment on product quality performance and post-market product quality analysis to lead quality related problem solving and root cause analysis during design and manufacturing and initiates field actions when required
• Supports stakeholders during the execution of quality system- and product audits and inspections.

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

• B.E. in Mechanical / Electrical / Electronic Engineering / MS in engineering preferred / Equivalent Degree
• 8 - 15 or more years of experience form Medical Devices / Personal Health
• Working Knowledge of global medical device regulations, requirements, and standards, such as 21 CFR Parts 803, 806, and 820, ISO13485, and ISO9001.
• Independently Produces and completes Quality Engineering Documents.
• Responsible for Performing timely, quality engineering tasks like : Assessing Quality Plans, product designs & reviewing tea and other performance data, analyses market feedback, lead root cause analysis and Quality problem solving
• Responsible for following major deliverables:
  • Post Market Surveillance plan / Periodic Quality review report
  • Safety Risk Management plan / matrix / report
  • Product reliability status
  • Hazardous substance management (risk management + declaration)
  • Bio compatibility assessment
  • Substance dispensation request (waiver)
  • Product Design Release
• Hands on experience on DOORS
• Hands on experience with Windchill & releases management
• Working with multiple stakeholders to align and ensure timely delivery and release in the Windchill
• Working knowledge of Microsoft Project, Excel, Power Point, and Word required
• Good team player
• Strong English written and verbal communication skills required

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.
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