Mechanical Designer-qpl

Philips

Onsite
5+ years quality assurance experience
Iso 13485 and fda 820 compliance knowledge
Design control and risk management expertise
The role is responsible for implementing comprehensive process validation plans and ensuring smooth transitions of new products to production

Job Summary

  • The role is responsible for implementing comprehensive process validation plans and ensuring smooth transitions of new products to production.
  • Candidates must ensure compliance with regulatory standards such as ISO 13485, FDA 820, and ISO 14971 throughout the product life cycle.
  • Philips is a health technology company dedicated to helping people everywhere access quality healthcare.

Matching Summary

The role is responsible for implementing comprehensive process validation plans and ensuring smooth transitions of new products to production.

Skills & Requirements

Must-have

  • 5+ years quality assurance experience
  • ISO 13485 and FDA 820 compliance knowledge
  • Design control and risk management expertise
  • Post-market analytics and root cause analysis
  • Engineering degree (BE) required

Nice-to-have

  • Experience in highly regulated industries
  • Strong influence and presentation skills
  • Dispute solving capabilities
  • Fluent English communication skills

Key Requirements

  • Bachelor of Engineering degree
  • Minimum 5 years in quality assurance
  • Knowledge of MDR/MDSAP regulations
  • Experience in medical industry preferred

Work Rights

Not specified

Tailored Resume

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