Description

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

This role is on-site.

Responsibilities

• Lead continuous improvement efforts for Quality Controls to reduce recalls and meet regulatory standards.
• Lead or participate in CAPA and non-conforming investigations, defining appropriate corrective actions.
• Act as the site Subject Matter Expert (SME) for quality 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 processes.
• Familiarity with product lifecycle management (PLM) systems.
• Experience with ERP systems (SAP is a plus).
• Experience with Quality Engineer principles and management system implementation.

Preferred Skills

• Working knowledge of FDA and/or ISO regulations.

Key Skills

Education

Bachelor's degree