Quality Engineer Ii

Dataroomspot

Base: $77,570 - $113,740; bonus/equity: cash-based...
Quality system requirements adherence
Medical device manufacturing compliance
Regulatory and standards compliance
The primary purpose of this job is to provide Quality Engineering support for Operations to ensure that the Quality System requirements are adhered to for medical device manufacturing/operations in accordance with applicable Regulatory and Standards requirements for compliance

Job Summary

  • The primary purpose of this job is to provide Quality Engineering support for Operations to ensure that the Quality System requirements are adhered to for medical device manufacturing/operations in accordance with applicable Regulatory and Standards requirements for compliance.
  • This role involves supporting regulatory and agency inspections, leading generation and completion of protocols and reports for test method validations, and developing various inspection techniques and procedures to ensure product integrity.
  • The company offers a comprehensive total rewards program including base salary, cash-based incentive program, medical, dental, vision, disability, life insurance, adoption benefits, parental leave, 401(k) with company matching, paid holidays, and paid time off.

Matching Summary

The primary purpose of this job is to provide Quality Engineering support for Operations to ensure that the Quality System requirements are adhered to for medical device manufacturing/operations in accordance with applicable Regulatory and Standards requirements for compliance.

Salary

Base: $77,570 - $113,740; Bonus/Equity: cash-based incentive program; Benefits: medical, dental, vision, disability, life insurance, adoption benefits, parental leave, 401(k) with company matching

Skills & Requirements

Must-have

  • Quality System Requirements Adherence
  • Medical Device Manufacturing Compliance
  • Regulatory and Standards Compliance
  • Test Method Validation Protocols
  • Process Validation and Capability Studies
  • Non-conforming Material Disposition
  • CAPA Activities Participation

Nice-to-have

  • Customer Success Focus
  • Innovation and Better Solutions
  • Collaboration and Team Success
  • Respectful Interaction
  • Open and Honest Communication
  • Integrity in Actions

Key Requirements

  • Bachelor’s Degree in Engineering or related field
  • 2-5 years quality engineering experience
  • Medical device or regulated manufacturing experience preferred
  • Proficiency in Microsoft Office and Minitab

Work Rights

Not specified

Tailored Resume

Cover Letter