Quality Engineer

About the role

The Quality Engineer will develop, implement, and maintain quality assurance plans, analyze data to drive continuous improvement, and provide technical mentorship to the quality assurance team. The role involves representing the quality function in technical support, collaborating with other internal support groups on issues affecting manufacturing on global customer accounts, and serving as a liaison between the company, suppliers, and customers on global quality-related issues.

Responsibilities

• Develop, maintain, and improve quality management system procedures to support governing standards
• Lead root cause analysis sessions with cross-functional working groups and assist with implementing corrective and preventive actions (CAPA) for non-conformances
• Analyze production and development data to identify trends, defects, and opportunities for improvement
• Support and review the execution of process validation protocols and test method validation, including development of measurement methods or functional test methods
• Provide support for all quoting activities by participating in initial process design, development, and implementation phases
• Evaluate and provide input to inspection processes via inspection aids and instruction guidelines
• Support global training programs specific to the customer by developing and implementing specialized training sessions for all applicable functions
• Develop appropriate systems for document storage, access, and review pertaining to global customer accounts
• Review all supplies, internal, and customer discrepancies, and coordinate and track the effectiveness of corrective and proactive action efforts
• Conduct periodic review and maintenance of all documentation files
• Participate in vendor survey activities and drive proactive participation with suppliers, aiding in their process improvement efforts when possible
• Interface with all departments as applied to the company's policies and procedures
• Provide insight and assistance in implementing and maintaining process improvement and optimization concentrating on proactive methodologies
• Assist in driving the standardization of manufacturing processes for global customer accounts
• Interface and provide technical support on quality issues with the customer as needed

Qualifications

• Minimum bachelor's degree in engineering, quality, or related technical field
• 5+ years of related experience in a quality engineering role, preferably in medical device manufacturing
• ASQ certification preferred

Essential Skills

• Proficiency in quality engineering, ISO standards, and medical device manufacturing
• Experience with supplier quality, root cause analysis, CAPA, and quality management systems (QMS)
• Proficiency in statistical analysis, statistical process control, root cause analysis tools, and risk management
• Strong analytical, leadership, and communication skills
• Experience with injection molded plastic parts and audit processes
• Proficiency with Minitab and standard Microsoft Office Suite, including Excel
• Experience with ERP systems such as SAP, Oracle, or IQMS

Work Environment

The position is based in a manufacturing environment, focusing on injection molding of medical products and adhering to ISO 13485 standards.

Job Type & Location

This is a Contract position based out of Gages Lake, IL. This is a fully onsite position.

Pay

The pay range for this position is $42.00 - $46.00/hr.