Quality Engineer II

Job Description:

Job Title: Quality Engineer II

Location: Fort Worth Texas 76137

Contract duration : 10+ months

Job Description

Senior Quality Engineering – Consultant

Technical Skills

Must Have

• CAPA Management
• Conduct Root Cause Investigation Analysis
• NCMR Disposition
• Senior Quality Engineering experience

Nice to Have

• Experience with Medical Devices or another highly regulated industry
• Experience in Problem Solving / Lean Six Sigma
• Experience in Statistical Methods or Data Analysis
• Experience in Process Validation
• High attention to detail and accuracy
• Effective English verbal and written technical communication and presentation skills
• ASQ CQE or CQA certification is a plus

Top 3 Required Technical Skills

1. Problem Solving / Root Cause Investigation / CAPA Management
2. Process Validation (including Test Method Validation)
3. Six Sigma

Job Description

Responsibilities may include the following and other duties as assigned:

• Develop, modify, apply, and maintain quality standards and protocols for processing materials into partially finished or finished products.
• Collaborate with Engineering and Manufacturing functions to ensure quality standards are established and maintained.
• Devise and implement methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and production equipment.
• Design or specify inspection and testing mechanisms and equipment.
• Conduct quality assurance testing and perform statistical analysis to assess costs and determine responsibility for products or materials that do not meet required standards and specifications.
• Ensure corrective actions and corrective measures meet acceptable reliability standards.
• Maintain compliant documentation in accordance with applicable requirements.
• Support activities related to product and process quality across various quality disciplines, including:
• • Design Quality
  • Incoming Material Quality
  • Production Control Quality
  • Product Evaluation & Reliability
  • Inventory Control
  • Research & Development Quality

The ideal candidate will possess strong expertise in quality engineering, root cause investigations, CAPA management, process validation, and Six Sigma methodologies, with experience in highly regulated environments preferred.