New 
Quality Engineer
 Koch Business Solutions, LP | |
life insurance, parental leave, mileage reimbursement
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 United States, Wisconsin, Hudson | |
 Feb 20, 2025 | |
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Your Job
Phillips-Medisize, a Molex Company is an end-to-end provider of innovation, development, and manufacturing solutions to the pharmaceutical, diagnostics, and medical device industries. Our Global Technical Services Team is seeking a Quality Engineer to support operations in our Hudson, WI. Travel between the other WI sites will be expected based on where the resources are needed. Mileage reimbursement will be provided per the Molex policy. This role will manage and provide Quality and Process Validation activities with the mutual goals of regulatory compliance and the provision of products/services that meet all customer expectations. Our Team Phillips Medisize, a privately owned, global CDMO, collaborates with industry leaders and innovators 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 and 29 development and manufacturing sites across three continents, Phillips Medisize shares our customers' mindset that every product is critical to a healthcare provider and their patients somewhere in the world. What You Will Do * Lead AQP processes, develop product quality criteria, and execute associated deliverables during new product introduction. * Serve as a communication liaison between the customer and manufacturing facility * Coordinate and lead Process Validation projects for injection molding, assembly, and inspection equipment and associated processes. * Create validation documentation and oversee validation executions. * Establish Bill of Materials, control prints, drawings, product specifications and test methods. * Coordinate quality system deliverables inclusive of quality events, deviations, MRBs, CAPAs, Batch Records, Inspection Plans, and Certificates of Compliance. * Establish quality system deliverables inclusive of quality events, deviations, MRBs corrections, CAPAs, Batch Records, and Certificates of Compliance. * Lead CAPA investigations and outcomes using data based, structured, problem-solving methodology. * Ensure adherence with customer Quality Agreements and other requirements * Travel to other Phillips-Medisize and vendor sites (up to 30%) * Implement systems and procedures that assure compliance with Quality and Validation standards. Share best practices and suggest improvement opportunities. * Development and implementation of statistical incoming and in-process sampling/control plans Who You Are (Basic Qualifications) * Bachelor's Degree OR 4+ years of direct Quality or Validation experience * 1+ year experience working in a regulated manufacturing environment; medical or pharmaceutical manufacturing What Will Put You Ahead * Excellent communication skills and the ability to effectively present information and respond to questions from managers, sales, and customers * Ability to identify problems, and develop and implement actions to resolve them * Ability to motivate and influence people * Good project management and leadership skills; self-motivated * Strong statistical data analysis capability * Experience in drug handling operations * Experience with SAP 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 [1] 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 [2] 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 [3] here for additional information. (For Illinois E-Verify information click [4] here, [5] aqui, or [6] tu). References Visible links 1. https://jobs.kochcareers.com/pages/culture 2. https://www.kochind.com/about/business-philosophy 3. https://www.e-verify.gov/sites/default/files/everify/posters/EVerifyParticipationPoster.pdf 4. https://labor.illinois.gov/content/dam/soi/en/web/idol/employers/posters/e-verify/Right%20to%20Privacy%20in%20the%20Workplace_English.pdf 5. https://labor.illinois.gov/content/dam/soi/en/web/idol/employers/posters/e-verify/Right%20to%20Privacy%20in%20the%20Workplace_Spanish.pdf 6. https://labor.illinois.gov/content/dam/soi/en/web/idol/employers/posters/e-verify/Right%20to%20Privacy%20in%20the%20Workplace_Polish.pdf | |