Quality Engineer

Phillips-Medisize, a Molex company is seeking a Quality Engineer to join our team in Hudson, Wisconsin at our Research and Development - North America facility.

This role will lead, support, organize, and coordinate activities of the quality function with the goal of providing products/services that meet customer expectations. Devise and implement continuous improvement methodology supporting manufacturing, support groups and ensure customer satisfaction is maintained.

At Phillips Medisize, our goal is to create value for others. We empower every team member to hear, feel and see the quality in every action we take. By incorporating quality into the design of products and processes and predicting potential quality problems before manufacturing and delivering the product, we can create mutual benefit. The leading task of quality control involves enforcing the use of specified processes and materials, ensuring the qualification of operators and equipment, and making a series of planned measurements to determine if quality standards are being met.

• Ensure compliance with FDA 21 CFR 820, 21 CFR 210/211, ISO 13485, ISO 14971, and other applicable quality system requirements.
• Lead validation and verification activities for manufacturing processes, equipment, and quality systems.
• Review product specifications, materials, and manufacturing processes to ensure quality, safety, and regulatory compliance.
• Manage quality system documentation, including change controls, nonconformance reports, investigations, CAPAs, and validation records.
• Investigate quality issues, perform root cause analysis, and implement corrective and preventive actions to drive sustainable solutions.
• Partner with suppliers and internal stakeholders to ensure quality requirements are met and continuously improved.
• Support customer complaint investigations and provide technical expertise to resolve manufacturing and field quality issues.
• Analyze quality metrics and trends to identify risks, improve performance, and reduce recurring issues.
• Champion continuous improvement initiatives that enhance product quality, compliance, and operational effectiveness.
• Collaborate across Engineering, Operations, Regulatory, and Quality teams while mentoring and supporting the development of junior engineers.

• Bachelor’s degree in an Engineering related field
• 5+ years Quality/Regulatory experience
• Experience with an ERP system, SAP preferred
• Data analysis experience

• Strong understanding of quality systems, risk management, and continuous improvement methodologies.
• Ability to investigate nonconformances, identify root causes (CAPA), and implement effective corrective actions.
• Experience interpreting technical drawings, specifications, and regulatory or customer requirements.
• Excellent analytical, problem-solving, and data-driven decision-making skills.
• Strong communication and collaboration skills with the ability to work effectively across cross-functional teams.
• Proficiency in statistical analysis and quality improvement tools such as SPC, Minitab, and FMEA.
• Strong interpersonal skills with the ability to influence and collaborate across engineering, operations, and quality teams.

This position does not qualify for VISA Sponsorship.

In order to comply with U.S. export control laws and regulations, this position requires applicants to either provide proof of U.S. citizenship or lawful permanent resident status or be eligible to receive an export authorization (a license) under the International Traffic in Arms Regulations and/or the Export Administration Regulations.

At Koch companies, we are entrepreneurs. This means we openly challenge the status quo, find new ways to create value…