Quality Engineer II

The Quality Engineer II provides Quality Engineering support for Operations to ensure compliance with Regulatory and Standards requirements for medical device manufacturing/operations. Provides work direction for 1-3 Technicians/Inspectors.

Requirements

• Adheres to Integer Core Beliefs and all safety and quality requirements
• Supports regulatory and agency inspections, audits, investigations, and inquiries
• Monitors manufacturing of assigned products, assuring compliance with DMR
• Reviews adequacy and correctness of changes to Bill of Materials, Assembly Procedures, Drawings, etc.
• Leads generation and completion of protocols and reports for test method validations
• Interfaces with Manufacturing Engineers to review processes for new and existing products
• Develops various inspection techniques and procedures to ensure product integrity
• Ensures that the disposition of non-conforming materials meet all necessary regulatory requirements
• Leads and manages complaint investigations
• Participates in plant CAPA activities, including analysis of data and trends
• Participates in continuous improvement projects
• Assists with product transfers
• Works with suppliers, management, Engineers and Manufacturing associates in the resolution of quality problems

Benefits

• Comprehensive benefits package
• Cash-based incentive program
• 401(k) plan with company matching contributions
• Paid time off
• Company designated holidays