Job Title: Manufacturing Quality Engineer

Job Description

We are seeking a dedicated Manufacturing Quality Engineer to lead quality assurance efforts in our manufacturing environment. This role is crucial in maintaining and enhancing the Quality Management System (QMS) and supporting manufacturing processes.

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.
• Develop and write QMS documents such as procedures, work instructions, and forms.
• 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.
• Perform equipment, facilities, and utilities qualification.
• Source, test, and qualify new and alternative sources of materials.
• Maintain equipment documentation, including engineering drawings, qualification and validation records, and operating manuals.
• Manage multiple concurrent projects supporting corrective, preventive, and improvement actions.

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.

Additional Skills & Qualifications

• 2+ years' experience in a regulated environment.
• Six Sigma Green Belt or Black Belt preferred.
• Experience communicating with customers and vendors and resolving non-conformances.
• Experience with medical device manufacturing.
• Experience with flexible packaging converting, including slitting, web flexography, pouch making, bag making, and die cutting.
• Experience with flexible packaging films.
• Bilingual in English/Spanish or English/Gujarati preferred.
• Bachelor of Science in Engineering or a Technical Field preferred, with emphasis on mechanical, electrical, packaging, biomedical, quality, or manufacturing engineering.

Work Environment

This role involves working in a dynamic manufacturing environment, focusing on both quality assurance and manufacturing engineering tasks. The position requires proficiency with various technologies and equipment, including statistical analysis software and 3-D CAD software. Team collaboration is essential, as is the ability to manage multiple projects simultaneously.