Quality Engineer

Key Responsibilities

• Create and maintain work instructions, standard operating procedures (SOPs), control plans, PFMEAs and train the production team in best practices and quality inspection techniques.
• Support the PPAP process for new product and process introductions, ensuring all necessary documentation, validations and approvals are in place for start of production.
• Lead investigations using problem-solving methodologies to identify root causes and implement corrective actions for quality issues such as, and not limited to: 8D problem-solving, Fishbone, FOG Analysis, 3 Legged 5 Whys and Pareto Analysis.
• Work with suppliers to provide detailed reports of part issues, including utilizing SCARs (Supplier Corrective Action Requests) to address non-conformances, investigate root causes, and ensure corrective actions are taken.
• Develop and perform incoming, calibration, line validations, and process audits to ensure compliance with product specifications, quality standards, and regulatory requirements.
• Identify areas for improvement and collaborate with cross-functional teams to implement continuous improvement initiatives.
• Monitor and manage deviations from standard processes, reviewing, documenting, and ensuring corrective and preventive actions are taken.
• Evaluate and approve process changes, ensuring they meet product specifications and regulatory requirements.
• Prepare comprehensive reports by collecting, analyzing, and summarizing data on quality metrics, product performance, and compliance audits, ensuring the information is clear and actionable for management.
• Communicate findings to management, providing actionable insights and recommendations for improving processes, reducing defects, and meeting quality goals.
• Lead/facilitate review and disposition of discrepant materials identified for control of nonconforming product through Material Review Boards (MRB)

Qualifications & Key Competencies

• 2 to 4 years previous experience in a manufacturing environment
• Skilled in measurement and visual inspection techniques
• Skilled in statistical data analysis and pivot charts
• Familiar with ISO 9001 standards, practices, and procedures
• Strong Microsoft Office application skills, including Excel, Word, and PowerPoint
• Self-motivated, with strong organizational skills and the ability to prioritize tasks in a demanding environment with high attention to detail
• Ability to work under pressure and achieve deadlines
• Ability to follow policies and procedures