Mechanical Designer-qpl

Philips

Onsite
5+ years quality assurance experience
Design control and new product development
Iso 13485 fda 820 iso14971 knowledge
The role is responsible for implementing comprehensive process validation plans to ensure smooth transitions of new products to production

Job Summary

  • The role is responsible for implementing comprehensive process validation plans to ensure smooth transitions of new products to production.
  • You will provide independent oversight of the design input process, verification activities, and design transfer to ensure regulatory compliance.
  • This position requires leading internal and external audits while ensuring all product documentation meets Quality System requirements.

Matching Summary

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

Skills & Requirements

Must-have

  • 5+ years quality assurance experience
  • Design control and new product development
  • ISO 13485 FDA 820 ISO14971 knowledge
  • Risk management and root cause analysis
  • Medical industry or regulated sector background

Nice-to-have

  • Strong influence and presentation skills
  • Dispute solving capabilities
  • Post-market analytics expertise
  • Continuous improvement mindset

Key Requirements

  • Bachelor of Engineering degree
  • Minimum 5 years in quality assurance
  • Fluent English writing and speaking
  • Experience with CFR 820.30 regulations

Work Rights

Not specified

Tailored Resume

Cover Letter