Description

You will own the development and implementation of quality programs to ensure products and processes meet specifications and regulations.

Responsibilities

• Lead continuous improvement efforts for Quality Controls to reduce recalls and meet regulatory standards.
• Lead or participate in CAPA and other non-conforming investigations, defining appropriate actions.
• Act as the site Subject Matter Expert (SME) for investigations.
• Collaborate with Operations, Regulatory, Product Development, Supplier Quality, and PMO to meet quality system requirements.
• Support the successful, on-time launch of new products and process transfers.

Required Skills

• 3+ years of quality engineering experience.
• Bachelor's degree in an Engineering discipline.
• Experience with Quality Inspection.
• Familiarity with Product lifecycle management systems.
• Experience with ERP systems (SAP is a plus).
• Working knowledge of FDA and/or ISO regulations is highly preferred.
• Experience with Quality Engineer principles.
• Familiarity with Management System implementation.

Key Skills

Education

Bachelor's degree