Supplier Quality Engineer - Direct Hire

Prestige Staffing Services is seeking an experienced Supplier Quality Engineer for a Direct Hire opportunity in Fort Wayne, Indiana. Our client is offering a highly competitive salary, excellent benefits, and outstanding company culture.

Primary Responsibilities

• Participate in supplier evaluations, quality agreements and audits as needed. Oversee supplier audit process and ensure all suppliers are audited as per set frequency.
• Travel to supplier location to oversee implementation of changes and/or to resolve production issues.
• Review validation protocols and reports for equipment and manufacturing processes including sterilization.
• Create, review and approve Risk Assessments and Supplier Corrective Actions for deviations and non-conformances at suppliers. May lead discussions and decisions for release of quarantined products based on Risk Assessments.
• Utilize effective and efficient Quality Engineering and Process Excellence tools and techniques such as root cause analysis, risk analysis, statistical data analysis, process capability analysis, design of experiments, measurement system analysis, control plans and development of sampling plans to aid in supplier development.
• Work with suppliers to ensure compliance with product specifications. Create or update new specifications based on changes to the product and processes. Help drive changes and improvements at suppliers for improving quality and product yield.
• Keep suppliers knowledgeable about failure modes and trend of the product as needed.
• Review and provide guidance for various non-conformance situations and investigations activities, evaluate root cause and corrective actions, and ensure documentation is complete, accurate, and closed in a timely manner.
• Be the key liaison between the company and the suppliers.
• Support the Supplier Management Program by managing Supplier Change Request (SCR).
• Support risk management activities for internal projects and processes.
• Identify compliance weaknesses and ensure the implementation of workable solutions. Communicate compliance requirements at all levels.
• Participate in continuous improvement projects. Establish and/or revise Key Process Indicators to help drive quality improvement projects.
• Provide training and guidance in the areas of government regulations to effected employees as well as to suppliers.
• Perform other related duties as required.

Requirements

• BS in an engineering science plus manufacturing experience, or an equivalent combination of education and experience.
• Ability to utilize statistical analysis and problem-solving techniques to determine product acceptance and evaluate process capabilities.