Quality Engineer

Precision Edge Surgical Products Company LLC

Not specified; not specified; not specified
Not specified
Bs in engineering required
3+ years quality engineering experience
Knowledge of iso 13485 and fda qsr 21cfr part 820
Precision Edge Surgical Products Company LLC is seeking a Quality Engineer with strong attention to detail and a solid understanding of manufacturing processes. The ideal candidate will have a background in quality engineering, experience with measurement equipment, and the ability to work effectively with both internal and external customers

Job Summary

  • The role requires a candidate with a BS in Engineering and at least three years of experience in quality engineering within a global industrial organization backed by Berkshire Hathaway.
  • Key responsibilities include creating inspection plans, facilitating corrective actions, and ensuring compliance with ISO 13485 and FDA QSR standards for surgical products.
  • The position offers diverse learning opportunities and fosters a culture where employees are empowered to lead at every level while making a positive impact on the world.

Matching Summary

Match Score: 85

Precision Edge Surgical Products Company LLC is seeking a Quality Engineer with strong attention to detail and a solid understanding of manufacturing processes. The ideal candidate will have a background in quality engineering, experience with measurement equipment, and the ability to work effectively with both internal and external customers.

Salary

Not specified; Not specified; Not specified

Skills & Requirements

Must-have

  • BS in Engineering required
  • 3+ years quality engineering experience
  • Knowledge of ISO 13485 and FDA QSR 21CFR part 820
  • Experience with PFMEA and Control Plans
  • Ability to interface with customers and suppliers

Nice-to-have

  • Six Sigma and SPC preferred
  • Design and Analysis of Experiments knowledge
  • Lean Manufacturing knowledge
  • Excellent interpersonal skills
  • Organizational and supervisory skills

Key Requirements

  • BS in Engineering degree
  • 3+ years experience in quality engineering
  • Knowledge of FDA QSR 21CFR part 820
  • Understanding of ISO 13485 standards

Work Rights

Not specified

Tailored Resume

Cover Letter