Junior Software QA Analyst
SmartLight Analytics
SQL
Supplier Quality Engineer
Exactech
full-time
Posted on:
Location: Florida • 🇺🇸 United States
Visit company websiteJob 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
