Exactech

Supplier Quality Engineer

Exactech

full-time

Posted on:

Location: Florida • 🇺🇸 United States

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Job Level

Mid-LevelSenior

About the role

  • Works with internal customers in support of supplier selection, approval, auditing, and monitoring
  • Serves as liaison between suppliers and internal customers to drive supplier quality improvement
  • Provides technical support for supplier assessments, change notifications, and supplier corrective actions
  • Implements quality-related programs and projects
  • Facilitates selection, development, qualification, approval and monitoring of suppliers
  • Leads supplier audits, supplier visits, and coordinates / leads supplier conference calls
  • Leads or participates in development or continuous improvement projects focused on supplier quality
  • Identifies supplier non-conformance (NPR) trends and provides technical support on NPR investigations
  • Works cross-functionally to establish inspection and test procedures and tracks supplier quality performance with Purchasing and QA
  • Establishes Quality Agreements and Exactech-Supplier Terms & Conditions with suppliers
  • Leads justification for supplier-based Deviation Requests and is actively involved in Supplier CAPAs
  • Participates in First Article Inspection (FAI) program and supports IQ, OQ, PQ protocol development and execution
  • Develops metrics, reports, and management review presentations as needed
  • Assists and supports other team members as necessary

Requirements

  • Bachelor’s Degree from an accredited institution required
  • Master’s Degree preferred
  • Minimum 5 years of experience in Supplier Quality Management and the medical device industry or other regulated industry (Automotive, Aerospace)
  • ISO 13485 Lead Auditor Certification or ability to complete certification within a year
  • Strong working knowledge of quality systems and risk management (ISO 13485, ISO 17025, ISO 14971, 21 CFR Part 820, Part 11)
  • Demonstrated ability to understand technical drawings and Geometric Dimensioning and Tolerancing (GD&T)
  • Working knowledge of process and product validation (IQ, OQ, PQ)
  • Demonstrated understanding of Failure Mode and Effects Analysis (Design & Process)
  • Demonstrated understanding of Statistical Techniques, including Statistical Process Control (SPC), and experience implementing SPC or similar controls
  • Approximately 25% travel, primarily for supplier audits; travel may include domestic and international locations
  • Ability to work effectively in a team environment
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