Staff Engineer, Advanced Quality

Orthopedicjobs

Hybrid
Product and process quality
Risk management activities
Design verification and validation
Partner with Engineering and Advanced Operations to define design requirements and develop manufacturing processes to support new product development projects

Job Summary

  • Partner with Engineering and Advanced Operations to define design requirements and develop manufacturing processes to support new product development projects.
  • Lead risk management activities to ensure the highest level of product and process quality.
  • Develop quality assurance documentation to support new product development process and regulatory submissions.

Matching Summary

Partner with Engineering and Advanced Operations to define design requirements and develop manufacturing processes to support new product development projects.

Skills & Requirements

Must-have

  • Product and process quality
  • Risk management activities
  • Design verification and validation
  • Medical Device Regulations
  • Statistical analysis techniques

Nice-to-have

  • Advocate for product excellence
  • Critical thinking
  • Outside the box thinking
  • Work independently

Key Requirements

  • BS in science, engineering or related discipline
  • Minimum of 5 years experience
  • Experience with medical device product development lifecycle
  • Experience interacting with regulatory agencies

Work Rights

Not specified

Tailored Resume

Cover Letter