New

Quality Manager

Koch Business Solutions, LP
life insurance, parental leave
United States, Wisconsin, Hudson
Apr 15, 2025
Your Job Phillips Medisize, a Molex Company, is seeking a contribution-motivated Quality Manager 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 Ensure compliance with regulatory requirements and internal procedures including notified body and regulatory inspection support Ensure effective stewardship of NPI programs and their successful progression to commercial production Provide coaching and development to your team of leaders, and ensure your entire organization is leveraging its individual and collective comparative advantage Develop and monitor Quality KPIs to drive continuous improvement within the quality system Ensure functional group collaboration on NPI program and other project support efforts Ensure proper establishment of requirements and ongoing compliance for drug handling and associated laboratory operations Actively contribute to a safe and inclusive workplace environment Who You Are (Basic Qualifications) Bachelor's degree or higher in a scientific discipline 7+ years of experience in Quality Assurance within the pharmaceutical, medical device, or biotechnology industry 5+ years of experience in a drug product development or manufacturing environment 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) Supervisory experience This position does not qualify for VISA Sponsorship. 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).