Quality Engineer Ii, Post Market Surveillance

techfreshers

Colorado, US
Base: $76,800.00 - $115,200.00 usd; bonus/equity: ...
Post market trending and data analysis
Health risk assessment documentation
Regulatory compliance with fda and iso standards
At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all

Job Summary

  • At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all.
  • This position offers the opportunity to work in a dynamic, innovative-driven environment where your analytical skills will directly impact product quality and patient safety.
  • Medtronic offers a competitive Salary and flexible Benefits Package including health insurance, 401(k) plan with employer match, paid time off, and employee stock purchase plan.

Matching Summary

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all.

Salary

Base: $76,800.00 - $115,200.00 USD; Bonus/Equity: Eligible for Medtronic Incentive Plan (MIP); Benefits: Health, dental, vision insurance, 401(k) with match, paid time off, employee stock purchase plan

Skills & Requirements

Must-have

  • Post Market trending and data analysis
  • Health Risk Assessment documentation
  • Regulatory compliance with FDA and ISO standards
  • CAPA investigations and corrective actions
  • Collaboration with Regulatory and R&D teams
  • Quality improvement project management

Nice-to-have

  • Experience with quality management software
  • Strong statistical analysis skills
  • Knowledge of global post-market surveillance regulations
  • Root cause analysis methodologies
  • Self-motivated and independent worker
  • Excellent communication and problem-solving skills

Key Requirements

  • Bachelor’s degree required
  • Minimum 2 years relevant experience or advanced degree
  • Knowledge of FDA 21 CFR Part 820 and ISO 13485
  • U.S. work authorization required at hire
  • Experience in post market surveillance or risk assessment

Work Rights

Must have unrestricted U.S. work authorization at hire

Tailored Resume

Cover Letter