Quality Engineer - Marinette, WI

The Quality Engineer position at ChemDesign is a full-time, on-site role located in Marinette, WI. This role is responsible for maintaining and improving quality systems, processes, and standards to ensure consistent product quality and compliance with ISO 9001:2015. This role also involves working closely with customers and internal stakeholders to address quality concerns, support continuous improvement initiatives, and uphold ChemDesign’s quality and safety culture.

Primary Responsibilities

• Maintain the business’s ISO 9001:2015 Quality Management System.
• Evaluate procedures and control systems to provide recommendations for continuous improvement.
• Apply strong chemical knowledge to troubleshoot and resolve process challenges.
• Conduct root cause analysis for quality issues and take corrective actions.
• Lead Continuous Improvement projects by facilitating engagement at all levels of the organization.

Key Functions

• Communicate directly with managers and plant personnel to act as lead and spearhead all initiatives within the QMS
• Facilitate monthly management review meetings.
• Develop, maintain, and improve documented procedures, work instructions, and technical standards
• Train staff on GMP practices, documentation standards, and quality policies.
•  Ensure compliance with ISO 9001, customer specifications, and internal quality standards throughout all stages of chemical production.
• Monitor and maintain batch record integrity, including documentation of deviations, investigations, and corrective actions.
• Collaborate with production, R&D, and EHS teams to evaluate process controls and identify opportunities for continuous improvement.
•  Maintain and improve the internal audit program. Oversee internal auditors to completion of corrective actions.
• Prepare for and participate in customer quality audits and regulatory inspections.
• Manage change control processes and assess the quality impact of proposed changes to materials, procedures, or equipment.
•  Develop, review, and update Standard Operating Procedures (SOPs) and Work Instructions (WIs).
• Use statistical tools (Excel) to analyze quality trends and support continuous improvement

General requirements

• Participate in development of plant performance metrics
• Extended hours or weekends may be required for special projects
• Proficient in Microsoft Office suite
• Must be able to perform group training sessions
• Champion strategic goal initiatives in quality and sustainability
• Shall not pose a threat to the health or safety of other individuals in the workplace
• Confident in audit environments with customers and regulatory bodies
• Spend time in the plants working with Operators to learn roles and responsibilities to be able to support process improvements

Leadership skills

• Decision and problem-solving skills
• Driven by a vision and able to set measurable objectives
• Goals tracked and posted as a dashboard
• Communication skills that engage and motivate staff
• Facilitate functionality across departmental lines
• Able to embrace change and lead others in adaptation

Educational/Skill requirements

•  BS degree in Chemistry, Engineering, or related science/engineering discipline
•  2–5 years’ experience in quality assurance or quality engineering, preferably in chemical manufacturing.
• Working knowledge of ISO 9001 Quality Management Systems, including document control, process auditing, corrective actions, and continuous improvement practices.
•  Knowledge of ISO 9001 or GMP systems.

Learn more here: https://chemdesign.com/careers/