Senior Quality Assurance Engineer

Cepheid

Newark, CA, United States
Base: $116,000-159,500; bonus/equity: eligible for...
Risk-based approach
Process fmeas
Verification and validation planning
The Senior Quality Engineer is responsible for supporting the development and sustainment of Medical Device manufacturing operations by applying a rigorous, risk-based approach that ensures compliance with corporate policies, 21 CFR 820, ISO 13485, and other relevant regulatory standards

Job Summary

  • The Senior Quality Engineer is responsible for supporting the development and sustainment of Medical Device manufacturing operations by applying a rigorous, risk-based approach that ensures compliance with corporate policies, 21 CFR 820, ISO 13485, and other relevant regulatory standards.
  • In this role, you will have the opportunity to lead daily quality engineering support for medical device manufacturing operations, including oversight of critical processes, equipment performance, and in-line quality inspections.
  • The annual salary range for this role is $116,000-159,500, and this job is also eligible for bonus/incentive pay.

Matching Summary

The Senior Quality Engineer is responsible for supporting the development and sustainment of Medical Device manufacturing operations by applying a rigorous, risk-based approach that ensures compliance with corporate policies, 21 CFR 820, ISO 13485, and other relevant regulatory standards.

Salary

Base: $116,000-159,500; Bonus/Equity: Eligible for bonus/incentive pay; Benefits: Comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k)

Skills & Requirements

Must-have

  • Risk-based approach
  • Process FMEAs
  • Verification and validation planning
  • Root cause analysis
  • CAPA implementation

Nice-to-have

  • Continuous improvement culture
  • Cross-functional team collaboration
  • Career growth and development
  • Tangible impact innovation

Key Requirements

  • BS degree in mechanical, industrial, biomedical engineering, or related field with 5+ years of quality engineering experience or master’s degree with 3+ years’ of quality experience
  • Strong understanding of ISO 13485, 21 CFR 820, and GMP requirements
  • Proven experience in NPI Quality and working with complex systems
  • Ability to travel domestically and internationally for up to 10% of the time

Work Rights

Not specified

Tailored Resume

Cover Letter