Quality Engineer

About the role

The Quality Engineer develops, implements, and maintains quality assurance plans and quality management system procedures, analyzes production and development data to drive continuous improvement, and provides technical mentorship to the quality assurance team. This role represents the quality function in technical support for global customer accounts, collaborates with internal support groups on manufacturing issues, and serves as a liaison between the organization and suppliers or customers on global quality-related matters.

Responsibilities

• Develop, maintain, and continuously improve quality management system procedures to support relevant governing standards and regulatory requirements.
• Create, implement, and maintain quality assurance plans and ensure timely execution of global new product introductions using Advanced Product Quality Planning and process optimization methodologies tailored to customer needs.
• Lead root cause analysis sessions with cross-functional teams and assist in implementing corrective and preventive actions (CAPA) to address nonconformances.
• Analyze production and development data to identify trends, defects, and opportunities for process and product improvement.
• Support and review the execution of process validation protocols and test method validation to ensure robust and compliant processes.
• Develop measurement system analysis (MSA) approaches and functional test methods as needed to support product and process verification.
• Provide quality engineering support for quoting activities by participating in initial process design, development, and implementation phases.
• Evaluate and provide input to inspection processes, including the development of inspection aids and clear instruction guidelines.
• Support global training programs specific to assigned customers by developing and implementing specialized quality and process training for applicable functions.
• Develop and maintain appropriate systems for document storage, access, and review related to global customer accounts.
• Review supplier, internal, and customer discrepancies, and coordinate, implement, and track the effectiveness of corrective and proactive action efforts.
• Conduct periodic reviews and maintenance of documentation files and ensure document control systems remain accurate, accessible, and up to date.
• Participate in vendor survey activities, drive proactive engagement with suppliers, and support their process improvement efforts when possible.
• Interface with all departments to ensure adherence to established policies and procedures and alignment with quality standards.
• Provide insight and assistance in implementing and maintaining process improvement and optimization initiatives, focusing on proactive methodologies.
• Assist in driving the standardization of manufacturing processes across global customer accounts to enhance consistency and efficiency.
• Interface with customers and provide technical support on quality issues as needed, ensuring timely and effective resolution.

Essential Skills

• Minimum bachelor's degree in engineering, quality, or a related technical field.
• At least 5 years of experience in a quality engineering role, preferably within medical device manufacturing.
• Hands-on experience with quality engineering in a manufacturing environment, including injection molded plastic parts and medical products.
• Strong knowledge of quality management systems (QMS), including developing, maintaining, and improving QMS procedures.
• Experience with ISO 13485 or similar medical device quality standards.
• Proficiency in statistical analysis and statistical process control (SPC).
• Demonstrated expertise in root cause analysis tools and methodologies.
• Experience implementing and managing corrective and preventive actions (CAPA) and corrective action plans.
• Proficiency in risk management techniques related to product and process quality.
• Ability to lead cross-functional root cause analysis and process improvement initiatives.
• Strong analytical skills with the ability to interpret complex data and identify trends.
• Effective leadership skills to mentor and guide quality assurance team members.
• Clear and professional communication skills, both written and verbal.
• Proficiency with Minitab for statistical analysis.
• Proficiency with standard Microsoft Office applications, including Excel.
• Experience working with ERP systems such as SAP, Oracle, or IQMS.

Additional Skills & Qualifications

• ASQ certification (such as Certified Quality Engineer or related) is preferred.
• Experience supporting new product introductions using Advanced Product Quality Planning (APQP).
• Background in process validation and test method validation in regulated environments.
• Experience developing measurement system analysis (MSA) and functional test methods.
• Familiarity with supplier quality management, including vendor surveys and supplier process improvement support.
• Ability to develop and deliver specialized training programs related to quality and process standards.
• Experience creating and managing document control systems for global customer accounts.
• Demonstrated ability to collaborate effectively with cross-functional teams across manufacturing, engineering, and supply chain.

Work Environment

This role operates in a manufacturing environment focused on injection-molded plastic components and medical products, aligned with ISO 13485 quality standards. The position involves close collaboration with production, engineering, and supplier teams on the shop floor and in office settings, working with statistical tools such as Minitab, standard Microsoft Office applications, and ERP systems including SAP, Oracle, and IQMS. The environment emphasizes structured processes, rigorous documentation, and adherence to medical device quality and regulatory requirements, supporting global customer accounts and continuous improvement initiatives.

Pay

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

Schedule

This is a fully onsite position in Park City, IL. This is a Contract position.