Walk through production lines, understand equipment and production processes.
Understand the current state information from site leaders and functional managers.
Understand current challenges and projects in place to improve performance.
Understand the project priorities, milestones, staffing needs and timelines.
Quality Document GAP Assessment, Alignment & Remediation
To understand Production Quality Issues and their root causes
Strong knowledge in application of Statistical rationale, in resolving operational problems.
Process validation experience
Warehouse optimization, Line/Plant transfer experience
Lead quality improvements and cost reduction projects.
Work closely with operations and the Business functions to ensure quality performance of product and process.
Understand KPI"s for monitoring of process and/or Product quality, perform analysis, and interpret trends, identifying and activating on appropriate actions as necessary
Top Skills:
Validation (IQ/OQ/PQ) hands on Experience
Medical device industry experience
Gap assessment & remediation
Validation Engineer
Location: Miami, FL
Job Description:
Walk through production lines, understand equipment and production processes.
Understand the current state information from site leaders and functional managers.
Understand current challenges and projects in place to improve performance.
Understand the project priorities, milestones, staffing needs and timelines.
Quality Document GAP Assessment, Alignment & Remediation
To understand Production Quality Issues and their root causes
Strong knowledge in application of Statistical rationale, in resolving operational problems.
Process validation experience
Warehouse optimization, Line/Plant transfer experience
Lead quality improvements and cost reduction projects.
Work closely with operations and the Business functions to ensure quality performance of product and process.
Understand KPI"s for monitoring of process and/or Product quality, perform analysis, and interpret trends, identifying and activating on appropriate actions as necessary
Top Skills:
Validation (IQ/OQ/PQ) hands on Experience
Medical device industry experience
Gap assessment & remediation
What You'll Do
Walk through production lines, understand equipment and production processes.
Understand the current state information from site leaders and functional managers.
Understand current challenges and projects in place to improve performance.
Understand the project priorities, milestones, staffing needs and timelines.
Quality Document GAP Assessment, Alignment & Remediation
To understand Production Quality Issues and their root causes
