Manufacturing Quality Engineer

Responsibilities

• Lead the company's quality assurance efforts in manufacturing.
• Establish and maintain the Quality Management System (QMS).
• Maintain certification of the QMS to applicable standards as determined by executive management.
• Establish and maintain the internal quality audit program.
• Manage verification (inspection) activities, including quality inspection staff.
• Manage document control staff to publish and maintain QMS controlled documents.
• Resolve non-conformances, perform root cause determination, and develop CAPA plans.
• Analyze and manage risk using tools like FMEA.
• Investigate root causes and write reports as required.
• Perform statistical analysis of processes and product conformance using Minitab and other tools.
• Manage the resolution of customer complaints.
• Perform and coordinate internal and external audits.
• Manage a staff of Quality Inspectors and Quality Administrator.
• Develop and improve manufacturing processes.
• Qualify and validate production equipment and processes.
• Source and/or design equipment, accessories, and/or modifications.
• Maintain equipment documentation, including engineering drawings, qualification and validation records, and operating manuals.

Essential Skills

• 2+ years' experience in a manufacturing environment.
• 2+ years' experience in a Quality Management System environment.
• Experience with Minitab or equivalent statistical analysis software.
• Proficiency in performing Process Capability (Cpk and Ppk) measurements and analysis.
• Experience in writing and managing controlled documents.
• Experience with CAPA systems and root cause investigation tools.
• Proficiency in MS Office software, including Excel and Word.