Quality Engineer - United States

Location(s): Menomonie, WisconsinCompany: Phillips MedisizeCareer Field: EngineeringJob Number: 189243Apply: JobPhillips Medisize, a Molex Company, is seeking a Quality Engineer to join our team in Menomonie, Wisconsin. This role will support, organize, and coordinate activities of the quality function with the goal of providing products/services that meet customer expectations. Devise and implement continuous improvement methodology supporting manufacturing, support groups and ensure customer satisfaction is maintained.Building: Red CedarOur TeamPhillips Medisize, LLC, a Molex company, is a leading global provider of medical molding and assembly services.What You Will DoEnsure compliance with FDA 21 CFR 820 210:211, ISO 13485, and ISO 14971.Review specifications and ensure adherence to material and process requirements.Oversee validation and verification of manufacturing processes and equipment.Manage documentation for change management and non-conformance reports.Lead investigations and root cause analysis of non-conformances.Author tech reports, CAPAs, compliant investigations, and validations.Maintain PFMEA/risk management documentsWork with suppliers to meet quality requirements.Support customer complaint management.Troubleshoot manufacturing and field issues.Analyze quality data and trends; identify improvement areas.Champion continuous improvement initiatives.Collaborate with cross-functional teams.Who You Are (Basic Qualifications)Bachelor's degree or Associates Degree OR equivalent experienceMinimum of 2 years of quality-related experienceWorking knowledge of regulatory requirements including FDA 21 CFR 820, ISO 13485Strong technical writing and problem-solving skillsWhat Will Put You AheadSAP experienceInjection molding experienceAt 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 PhilosophyAll 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 AreAs 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 BenefitsOur 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 OpportunitiesEqual 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, aquí, or tu).