Quality Engineer

Position Overview

Our Global Technical Services team is seeking a contribution-motivated Quality Enginee
r to support operations in our Hudson, WI site and other Wisconsin locations. You will create value by stewarding New Product Introductions (NPI) with your background in Medical Device Quality Assurance, a passion for ensuring the highest standards in product quality and compliance, and a commitment to excellence.

• l Do Lead quality assurance activities for new product introduction (NPI) projects to ensure compliance with regulatory requirements (FDA, GMP, ISO 13485, etc.) Develop and maintain quality plans for new medical device product introduc
• Perform audits and inspections of NPI processes to ensure adherence to internal and external quality stan dards
• Manage and oversee quality documentation, including specifications, validation reports, and product dos iers
• Manage SAP activities such as generating and maintaining Quality Notifications, Document Control, Batch Records, Calibrations, and RMA/complaint sy stems
• Work with project teams and Validation leads to define the validation str a gy Draft MVPs, equipment qualification, protocol/test case, deviations and summary report documentation for project wr ap up
• Support regulatory submissions by compiling and reviewing quality-related document ation
• Monitor product performance during initial production runs to identify opportunities for improv ement
• Facilitate training and knowledge sharing across teams regarding quality expectations and best practi ces
• Stay informed of industry trends and regulatory updates to ensure compliance and competitiv eness
• Lead risk management activities including Process FMEA and Control Plans
• Collaborate with suppliers on quality requirements and audits to ensure component and material qu ality
• Facilitate root cause investigations and corrective actions for quality issues during product l aunch
• Conduct quality reviews and ensure alignment with internal standards and external regulatory bodies
• Assist with documentation and audit readiness for FDA inspections and ISO 13485 certific ation
• Drive continuous improvement efforts to enhance product quality and manufacturing proc esses Role requires intermittent travel to support engineering efforts at other Phillips Medisize sites or vendor sites

• tions) Bachelor’s degree in engineering, Quality, Life Sciences, or relate
• Experience with FDA QSR, ISO 13485, and medical device regulatory envi rment
• Strong knowledge of quality tools such as SPC, Process Capability, RCA, FMEA, 8 D, CAPA Excellent problem-solving skills and ability to work cross-funct ionally
• Experience with product validation, verification, and risk management in medical devices
• Legal authorization to work permanently in the United States for any employer without requiring a visa transfer or visa spon ship

This role is not eligible 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.

Equal Opportunity Employer, including disability and protected veteran status. Except where prohibited by state law, some offers of employment are conditioned upon successfully passing a drug test. This employer uses E-Verify. Please  for additional information. (For Illinois E-Verify information , aquí, or tu).