Quality Engineer

Koch Business Solutions, LP
life insurance, parental leave
United States, Wisconsin, Hudson
Jul 02, 2025
Your Job Phillips Medisize, a Molex Company, is seeking a contribution-motivated Quality Engineer to join our St. Croix Meadows manufacturing facility in Hudson, WI. You will create value by stewarding New Product Introductions (NPI) with your background in pharmaceutical quality assurance, a passion for ensuring the highest standards in product quality and compliance, and a commitment to excellence. Our Team Phillips Medisize is an end-to-end provider of innovation, development, and manufacturing solutions to the pharmaceutical, diagnostics, and medical device industries. We work collaboratively within our Global Quality Organization to deliver compliant and effective solutions to our customers. What You Will Do Lead quality assurance activities for new product introduction (NPI) projects to ensure compliance with pharmaceutical regulatory requirements (FDA, GMP, ICH, etc.). Oversee proper handling, storage, and transportation of pharmaceutical drugs during NPI processes to maintain product integrity and quality. Collaborate with R&D, manufacturing, and supply chain teams to establish quality standards and processes for new products. Ensure compliance with regulations related to controlled substances, hazardous material handling, and cold chain logistics Develop and implement quality plans, risk assessments, and validation protocols for NPI projects. Conduct root cause analysis and drive corrective and preventive actions (CAPAs) for project-related quality issues. 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. 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. Who You Are (Basic Qualifications) Bachelor's degree or higher in a scientific discipline 3+ years of experience in Quality Assurance within the pharmaceutical, medical device, or biotechnology industry 3+ years of direct experience in drug manufacturing Highly competent working knowledge of ICH and relevant CFRs and other industry guidelines Proficiency in quality management tools, methodologies (e.g., risk assessment, root cause analysis, FMEA), and software systems What Will Put You Ahead Proven experience in GxP audits, quality management systems, and CAPAs Strong analytical skills for data analysis and trend identification Competency in statistical tools and process validation Effective cross-functional collaborator with teams such as Regulatory Affairs and CMC (Chemistry, Manufacturing, and Controls) 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 and get rewarded for our individual contributions. Any compensation range provided for a role is an estimate determined by available market data. The actual amount may be higher or lower than the range provided considering each candidate's knowledge, skills, abilities, and geographic location. If you have questions, please speak to your recruiter about the flexibility and detail of our compensation philosophy. Hiring Philosophy All Koch companies value diversity of thought, perspectives, aptitudes, experiences, and backgrounds. We are Military Ready and Second Chance employers. Learn more about our hiring philosophy here. Who We Are As a Molex company, Phillips-Medisize mobilizes and deploys specialized capabilities and services across highly regulated industries, including health care, regulated consumer, automotive and defense. We design, develop and create innovative and life-changing medical technologies for millions of people around the globe. At Koch, employees are empowered to do what they do best to make life better. Learn how our business philosophy helps employees unleash their potential while creating value for themselves and the company. 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. Additionally, everyone has individual work and personal needs. We seek to enable the best work environment that helps you and the business work together to produce superior results. Equal Opportunities 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 click here for additional information. (For Illinois E-Verify information click here, aqui, or tu). #LI-MK4