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Design Quality Manager - Medical Devices

12-17 years

Pune

1 vacancy

Design Quality Manager - Medical Devices

Philips

posted 6d ago

Job Description

  • Driving compliance of Design control requirements and ensure product design quality met in new product development as well released product.
  • Ensuring radiation safety regulations and requirements as per IEC standard / FDA guidelines are met in the product design
  • Challenge the status quo on EMI/EMC impacts during product design change
  • Collaborating with RD Compliance team for CDR development in NPI
  • Monitoring design control requirements are adhered in the NPI project as part of project core team
  • Providing appropriate decision on project readiness to next phase / milestone considering quality aspects
  • Providing necessary process guidance and compliant solution to project team
  • Challenge the status quo of Reliability targets in NPI project
  • Deriving business solution by collaborating with cross functional team members
  • Provide support on E2E process guidance for issues reported on released product
  • Establish and support best practices for problem solving, root cause analysis, and solution selection tools
  • Provide subject matter expertise during internal and external quality system audits

Youre the right fit if you have:
  • Minimum with an Engineering degree of any discipline with 12+ years of relevant industry experience
  • Working experience in Systems and Software Engineering, Design Quality or Reliability Engineering
  • Medical Devices experience is mandatory including pre and post market activities.
  • Ability to define detailed design quality and reliability plans for new medical product developments including design transfer to ensure products 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 VV 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 60601, IEC 62366, IEC 62304 and ISO 14971
  • Experience with working in multidisciplinary teams in a high-tech RD 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 chang

Employment Type: Full Time, Permanent

Read full job description

Prepare for Quality Manager roles with real interview advice

Top Philips Quality Manager Interview Questions

Q1. Write a code to find distance between two points without using data structures
Q2. What will you do if you want to do some operation which involves rigorous mathematics?
Q3. How you will manage the supply chain knowing that the retailers will not stock your material on a large basis.
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What people at Philips are saying

Quality Manager salary at Philips

reported by 2 employees with 10-18 years exp.
₹21.1 L/yr - ₹27 L/yr
97% more than the average Quality Manager Salary in India
View more details

What Philips employees are saying about work life

based on 1.5k employees
78%
70%
49%
95%
Flexible timing
Monday to Friday
No travel
Day Shift
View more insights

Philips Benefits

Health Insurance
Work From Home
Job Training
Cafeteria
Team Outings
Soft Skill Training +6 more
View more benefits

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Philips Pune Office Location

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Pune Office
Philips Medical System, No.6, 2nd Floor, Dinkar Smruti, Shivajinagar, Bhamburda Pune
Maharashtra 411005

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