Quality Engineer

Description

Quality Engineer will be responsible for performing various duties such as owning and managing CAPA's. Execute supplier quality audits, and supplier selection. Perform internal and external audits for quality management. Quality Engineer will perform design of experiment for various validations and root cause analysis for quality issues.

Additional Skills & Qualifications

• Lead in addressing Customer Complaints including response to customers, communications of actions and updates to CMP processes, product requirements, and procedures.
• Lead in Corrective and Preventative Action (CAPA) system.
• High level participation in New Product Development working closely with cross functional teams, including product development, product management and production, to identify and mitigate quality risks.
• High level experience with CMP product, processes, and procedures.
• Experienced with ISO 13485 Standard, and FDA CFR Part 820 regulations
• Establishes quality standards for products and processes and suggest modifications meant to prevent defects in components or final products.
• Skilled in collecting and analyzing quality data with Statistical Process Control (SPC) support.
• Assist with process validation; process capabilities; and process improvements.
• Review and approve proposed manufacturing and specification changes.
• Exercise high level judgment to define manufacturing requirements and processes using Lean Manufacturing concepts.
• Analyze product, customer, and regulatory requirements to determine tools, fixtures and equipment requirements for assigned projects.
• Oversee processes and procedures against actual practices and update ensure compliance and provide improvement for processes and procedures.
• Participate in Kaizen Events (Lean) and follow-up implementation.