Your Job Phillips-Medisize, a Molex Company, is seeking a Quality Engineer to join our teams in Wisconsin. We have opportunities available at our  New Richmond, Menomonie, and Hudson  facilities. This role will 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. Our Team Phillips-Medisize, LLC, a Molex company, is a leading global provider of medical molding and assembly services. What You Will Do Ensure compliance with FDA 21 CFR 820 210:211, ISO 13485, and ISO 14971. Review specifications and ensure adherence to material and process requirements. Oversee validation and verification of manufacturing processes and equipment. Manage documentation for change management and non-conformance reports. Lead investigations and root cause analysis of non-conformances. Author tech reports, CAPAs, compliant investigations, and validations. Work with suppliers to meet quality requirements. Support customer complaint management. Troubleshoot manufacturing and field issues. Analyze quality data and trends; identify improvement areas. Champion continuous improvement initiatives. Mentor junior quality engineers. Collaborate with cross-functional teams. Who You Are (Basic Qualifications): Bachelor's degree or equivalent experience Minimum of 4 years of quality-related experience in a medical manufacturing environment Experience working in a regulated environment Knowledge of automated assembly and test procedures Working knowledge of regulatory requirements including FDA 21 CFR 820, ISO 13485 Experience working with an ERP system (SAP) Strong data analysis skills Strong technical writing and problem-solving skills Experience in packaging, serialization, sterilization, and complaint handling Experience with updating the test procedures in testing equipment What Will Put You Ahead: Experience in supplier quality management Pharmaceutical experience LI-SD5 Our Benefits Our goal is for each employee, and their families, to live fulfilling and healthy lives. We provide essential resources and support to build and maintain physical, financial, and emotional strength - focusing on overall wellbeing so you can focus on what matters most. Our benefits plan includes - medical, dental, vision, flexible spending and health savings accounts, life insurance, ADD, disability, retirement, paid vacation/time off, educational assistance, and may also include infertility assistance, paid parental leave and adoption assistance. Specific eligibility criteria is set by the applicable Summary Plan Description, policy or guideline and benefits may vary by geographic region. If you have questions on what benefits apply to you, please speak to your recruiter.