Quality Engineer - Operations

Department: Quality

Employment Type: Full Time

Location: Gainesville, FL

Reporting To: Manager QA Quality Operations Engineer

Description

The Engineer Quality Operations shall provide quality engineering support in quality assurance, control, and preventative activities with a focus on continuous improvement of internal products and processes. Support supplier quality issues impacting daily operations. Support the execution of initiatives and projects to enhance quality performance within the business and for our customers. Ensure compliance to regulation and standards. 

Key Responsibilities

• Develop and validate statistical methodologies and quality inspection sampling plans for internally manufactured and vendor supplied products, processes, and components. 
• Support qualification of in house or vendor supplied inspection equipment.
• Support disposition non-conforming (NC) product within MRB, coordinating related containment and investigation actions for timely NC closure.
• Responsible for organizing, assisting with, and documenting Stock Audits for potentially nonconforming product.  
• Initiate and provide support for distributed product risk assessments and health hazard evaluations.  Provide information and records to management regarding potential field actions.
• Communicate with suppliers regarding NC, escalating supplier corrective action requests as required. 
• Support manufacturing transfer between sites/facilities/suppliers.
• Performs general assessment of internal and supplier proposed change management activities. 
• Identifies and implements quality system improvements.  
• Support Key Performance Indicators (KPIs) for monitoring of process, quality, perform analysis, and interpret trends, identifying on appropriate actions as necessary.
• Understanding of risk management practices and concepts and applying knowledge to operation
• Perform Root Cause Analysis and support in Corrective and Preventive Actions 
• Participate in development and improvement of internal manufacturing processes for existing products.
• Support continuous improvement actions to reduce defects and improve process performance.
• Support inspection training for QC inspectors or QA technicians. 
• Perform process audits and GEMBA walks in support of compliance and continuous improvement
• Assist and support cross functional team members as necessary.
• Know and apply the Quality System and any appropriate Federal and International standards. 

Skills Knowledge and Expertise

Education:

• Bachelor’s Degree in a science, engineering or related discipline from an accredited institution required.

 Experience:

• Minimum 3 years’ experience or equivalent in highly regulated industry, medical device experience preferred
• Experience in GD&T and use of advanced inspection equipment

Functional/Technical Knowledge, Skills and Abilities Required:

• Advanced level of technical software proficiency
• Excellent Quality System knowledge required