Staff, Quality Engineer

embecta

Parsippany, NJ, United States
Base: $126,600 - $167,750; bonus/equity: eligibili...
Hybrid
Post market surveillance process
Complaint trending analysis
Regulatory compliance knowledge
embecta is a global diabetes care company leveraging its 100-year legacy in insulin delivery to empower people with diabetes through innovative solutions and passionate employees

Job Summary

  • embecta is a global diabetes care company leveraging its 100-year legacy in insulin delivery to empower people with diabetes through innovative solutions and passionate employees.
  • The Staff Quality Engineer supports the development and implementation of post market surveillance processes, leads investigations, and collaborates with multiple internal teams to improve product quality and regulatory compliance.
  • The company offers a competitive Total Rewards program including base salary, annual bonus eligibility, medical, dental, vision, retirement savings plans, and paid time off.

Matching Summary

embecta is a global diabetes care company leveraging its 100-year legacy in insulin delivery to empower people with diabetes through innovative solutions and passionate employees.

Salary

Base: $126,600 - $167,750; Bonus/Equity: Eligibility for annual bonus; Benefits: Medical, dental, vision, retirement savings plans, paid time off

Skills & Requirements

Must-have

  • Post market surveillance process
  • Complaint trending analysis
  • Regulatory compliance knowledge
  • Quality systems and tools
  • Data analysis for quality issues
  • Microsoft Office proficiency

Nice-to-have

  • Team collaboration skills
  • Analytical thinking and problem solving
  • Self-motivated and directed
  • Effective communication skills
  • Growth-centered culture

Key Requirements

  • BS Degree in Engineering or related field
  • 8+ years medical device industry experience
  • Knowledge of FDA, ISO 13485, ISO 14971, EU MDR, Canadian MDR, Japan PMDA regulations
  • Experience drafting PSURs
  • Certified Quality Engineer and Auditor preferred

Work Rights

Not specified

Tailored Resume

Cover Letter