Hybrid Supplier Quality Engineer II - QA, CAPA & Audits

Omnicell, Inc.

Northern (KY)

Hybrid

USD 65,000 - 93,000

Full time

4 days ago
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Benefits offered by this job

Hybrid work environment
Comprehensive benefits

Job summary

Omnicell, Inc. is seeking a Supplier Quality Engineer II to ensure supplier quality across manufacturing and service suppliers. You will analyze supplier performance data, lead SCAR/CAPA activities, and collaborate with Global Supply Chain, Development, and Manufacturing teams.

The role requires 3+ years in quality/manufacturing with ISO/FDA experience, plus travel up to 30% (domestic and international). Hybrid work in Warrendale, PA with a comprehensive benefits package.

Qualifications

  • Minimum 3 years quality/manufacturing experience.
  • BS Degree in Engineering or Technical Science.
  • ISO 13485 or FDA regulated medical device experience.
  • ISO 9001, ISO 14001, 21CFR820 experience.
  • Certified Lead Auditor (preferred).

Responsibilities

  • Data collection, analysis, and trending of supplier performance data.
  • Lead SCAR activities and coordinate CAPA processes.
  • Audit suppliers to meet Omnicell quality standards and regulatory requirements.
  • Develop and implement strategies to improve supplier performance.
  • Support component qualifications with New Product Introduction teams.

Skills

ISO auditing
Quality tools
Engineering drawings
MS Office

Education

BS in Engineering

Tools

ERP systems
PLM

Job description

Omnicell, Inc. is seeking a Supplier Quality Engineer II to ensure supplier quality across manufacturing and service suppliers. You will analyze supplier performance data, lead SCAR/CAPA activities, and collaborate with Global Supply Chain, Development, and Manufacturing teams.

The role requires 3+ years in quality/manufacturing with ISO/FDA experience, plus travel up to 30% (domestic and international). Hybrid work in Warrendale, PA with a comprehensive benefits package.

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