Quality Engineer

Job Overview

Our Global Technical Services team is seeking a contribution-motivated Quality Engineer to support operations in our New Richmond, 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.

Phillips Medisize, a Molex company, collaborates with industry leaders to design and manufacture drug delivery systems, medical devices and diagnostic tools that save and improve the quality of life for millions of patients annually. With our dedicated team of 6,000+ employees in 29 locations around the world, we share our customers' mindset that every product is critical to a healthcare provider and their patients somewhere in the world.

• 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 introductions
• Perform audits and inspections of NPI processes to ensure adherence to internal and external quality standards
• Manage and oversee quality documentation, including specifications, validation reports, and product dossiers
• Work with project teams and Validation leads to define the validation strategy
• Draft MVPs, equipment qualification, protocol/test case, deviations and summary report documentation for project wrap up
• Support regulatory submissions by compiling and reviewing quality-related documentation
• Monitor product performance during initial production runs to identify opportunities for improvement
• Facilitate training and knowledge sharing across teams regarding quality expectations and best practices
• Stay informed of industry trends and regulatory updates to ensure compliance and competitiveness
• Lead risk management activities including Process FMEA and Control Plans
• Collaborate with suppliers on quality requirements and audits to ensure component and material quality
• Facilitate root cause investigations and corrective actions for quality issues during product launch
• 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 certification
• Drive continuous improvement efforts to enhance product quality and manufacturing processes

• Bachelor's degree in Engineering, Quality, Life Sciences, or related field
• Experience with FDA QSR, ISO 13485, and medical device regulatory environment
• Strong knowledge of quality tools (ex. SPC, FMEA, 8D, or CAPA)
• Excellent problem-solving skills and ability to work cross-functionally
• 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 sponsorship

This role is not eligible for VISA sponsorship.

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.