{"id":1559239,"url":"https://alion.io/job/dupont-spectrum-quality-engineer-i","title":"Quality Engineer I","company":{"id":2041994,"name":"DuPont™ Spectrum™","domain":"spectrumplastics.com","url":"https://alion.io/company/spectrumplastics","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Paycom","truth_index":null},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"junior","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Pleasant Prairie, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":60000,"max_usd":108000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":4038},"experience_years_min":3,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"Microsoft Office","optional":true}],"status":"live","first_seen_at":"2026-10-01T03:24:53Z","employer_posted_date":"2026-10-06","last_verified_at":"2026-10-20T13:09:09Z","board_verified":true,"closed_at":null,"days_open":20,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":20},"description":"The Quality Engineer is responsible for overseeing process control, risk management, and product quality assurance for the medical tubing extrusion and blown film processes at the Pleasant Prairie, Wisconsin site. This role ensures compliance with ISO and cGMP standards while driving improvements in product quality, addressing customer complaints, and managing Corrective and Preventive Actions (CAPA). The Quality Engineer will collaborate closely with cross-functional teams to resolve quality issues, ensure regulatory compliance, and enhance product performance. Additionally, this position will manage clean room operations, calibration activities, and the development of quality procedures to support ongoing process optimization.\nAct as a role model and ensure safety is built into our QMS and work processes.\nOversee process control activities within the tubing extrusion process to ensure product quality, minimize defects, and meet regulatory standards.\nManage customer complaints by investigating root causes, developing action plans, and ensuring timely resolution to maintain high customer satisfaction.\nLead the CAPA process, ensuring corrective and preventive actions are properly documented, tracked, and implemented to address any quality issues.\nCollaborate with cross-functional teams to identify areas for improvement in the extrusion process, implementing solutions to enhance product quality and compliance.\nConduct root cause analysis and implement corrective actions for non-conformances, ensuring CAPA processes are followed and effectively closed.\nDevelop and maintain standard operating procedures (SOPs) to support and enhance the Quality Management System, ensuring ongoing regulatory compliance.\n\nMonitor and manage clean room operations, ensuring adherence to ISO and internal standards for contamination control.\nSupervise quality technicians, ensuring they are properly trained and follow standardized procedures for inspection and quality control.\nLead internal audits, identifying quality issues and ensuring corrective actions are implemented to maintain compliance with internal and external standards.\nParticipate in product validations, ensuring that new products meet quality standards and customer requirements before release.\nEvaluate new product specifications, ensuring they are aligned with customer requirements and regulatory standards.\nGenerate detailed reports for management meetings, highlighting product quality, risk analysis, customer complaints, and CAPA performance.\nSupport training programs to ensure all employees are knowledgeable about quality procedures, process controls, and CAPA requirements.\nEnsure full compliance with internal EHS policies, national laws, and industry regulations, maintaining a safe and compliant work environment.\nFoster a strong focus on product quality assurance, ensuring all products meet specifications and regulatory standards.\nOther duties as required. \nQualifications\nA degree in Engineering, preferably Mechanical or Industrial Engineering.\nSix Sigma Certification (desirable) to support process control and quality improvement efforts.\nInternal ISO Auditor certification (desirable) to lead audits and ensure compliance with ISO standards.\nProficiency in MS Office Suite for data analysis, reporting, and documentation.\nAdvanced statistical analysis skills with experience in tools such as Minitab, Gage R&R, Hypothesis Testing, and Design of Experiments (DOE).\nStrong experience with CAPA processes, implementing corrective and preventive actions to address quality issues and ensure compliance.\nClean Room Management experience, including managing cleaning schedules and contamination control measures.\nTubing extrusion experience, with a focus on quality control and process optimization.\nA minimum of three years of experience in a medical device manufacturing environment, with expertise in product quality assurance and risk management.","description_format":"text","description_chars":3941,"description_truncated":false,"requirements":{"experience_years_min":3,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"master","optional":true},"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Health Care","Manufacturing","Plastics & 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