Senior Supplier Quality Engineer – NPI & CAPA Leader

RXinsider LTD.

Cranberry Township (Butler County)

On-site

USD 90,000 - 130,000

Full time

5 days ago
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Job summary

Omnicell is seeking a Senior Supplier Quality Assurance Engineer III based in Cranberry Township, PA. This high-visibility role ensures quality standards across Omnicell’s global manufacturing and service supply base, with emphasis on New Product Introductions.

You will collaborate with Global Supply Chain and engineering to root-cause issues and drive corrective actions with suppliers. The position requires leadership in quality systems, audits, and continuous improvement, with up to 30% travel

Qualifications

  • Proven auditing methods for ISO 9001 and ISO 13485.
  • Knowledge of Pareto, fishbone diagrams, FMEA.
  • Engineering and manufacturing terminology familiarity.
  • Strong ownership of projects from start to finish.
  • Excellent reading of engineering drawings.

Responsibilities

  • Lead design-for-manufacturability discussions with internal teams.
  • Manage supplier qualifications for NPI and sustaining changes.
  • Lead development of IQ/OQ/PQ protocols and final reports with valid sampling sizes.
  • Guide suppliers to implement controlled processes with PFMEA and SPC.
  • Lead SCAR activities and CAPA to address supplier quality issues.
  • Plan and execute supplier audits to meet quality and regulatory requirements.
  • Collect, analyze, and trend supplier performance data from ERP/PLM.
  • Create metric reports for internal reviews and supplier QBRs.
  • Develop and implement strategies to improve manufacturing and service supplier performance.

Skills

ISO 9001 audit
ISO 13485 audit
Quality tools
FMEA knowledge
Sheet metal forming
Injection molding
Cross-functional teamwork
Communication skills
Project management
Self-starter

Education

BS Degree in Engineering or Technical Science

Tools

MS Office

Job description

Omnicell is seeking a Senior Supplier Quality Assurance Engineer III based in Cranberry Township, PA. This high-visibility role ensures quality standards across Omnicell’s global manufacturing and service supply base, with emphasis on New Product Introductions.

You will collaborate with Global Supply Chain and engineering to root-cause issues and drive corrective actions with suppliers. The position requires leadership in quality systems, audits, and continuous improvement, with up to 30% travel

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