Quality Engineer - Supplier Assurance

Carl Zeiss Pty Ltd

Base: $97,800 – $122,300 annually; bonus: performa...
5+ years quality assurance experience
Medical device manufacturing knowledge
Ncr and capa process expertise
This role ensures the quality, reliability, and compliance of products sourced from external suppliers within the medical device industry

Job Summary

  • This role ensures the quality, reliability, and compliance of products sourced from external suppliers within the medical device industry.
  • The position requires leading risk management activities, supplier audits, and implementing corrective actions to meet strict regulatory standards.
  • Employees receive a competitive annual salary range, performance-based bonuses, and comprehensive benefits including medical, dental, vision, and 401k matching.

Matching Summary

This role ensures the quality, reliability, and compliance of products sourced from external suppliers within the medical device industry.

Salary

Base: $97,800 – $122,300 annually; Bonus: Performance-based bonus eligible; Benefits: Medical, Vision, Dental, 401k Matching, EAP, Vacation

Skills & Requirements

Must-have

  • 5+ years Quality Assurance experience
  • Medical device manufacturing knowledge
  • NCR and CAPA process expertise
  • Process validations IQ OQ PQ
  • ISO and FDA-GMP regulatory standards

Nice-to-have

  • Master's degree in Engineering
  • CQE certification preferred
  • Statistical analysis proficiency
  • Cross-functional collaboration skills

Key Requirements

  • Bachelor's degree in Engineering or Life Sciences
  • Minimum 5 years in medical device/pharma QA
  • Hands-on experience with NCR and CAPA processes
  • Strong knowledge of ISO and FDA-GMP regulations

Work Rights

Not specified

Tailored Resume

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