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Spectrum Plastics Group, A DuPont Business · 1 day ago

Quality Engineer I

Pleasant Prairie, WI

Full-time

Onsite

Mid Level

3+ years exp

Spectrum Plastics Group, a DuPont Business, is seeking a Quality Engineer I to oversee process control, risk management, and product quality assurance for medical tubing and blown film processes. The role involves ensuring compliance with ISO and cGMP standards, managing customer complaints, and collaborating with cross-functional teams to enhance product quality and compliance.

ManufacturingMedical DevicePlastics and Rubber Manufacturing

H1B Sponsor Likely

Responsibilities

Act as a role model and ensure safety is built into our QMS and work processes

Oversee process control activities within the tubing extrusion process to ensure product quality, minimize defects, and meet regulatory standards

Manage customer complaints by investigating root causes, developing action plans, and ensuring timely resolution to maintain high customer satisfaction

Lead the CAPA process, ensuring corrective and preventive actions are properly documented, tracked, and implemented to address any quality issues

Collaborate with cross-functional teams to identify areas for improvement in the extrusion process, implementing solutions to enhance product quality and compliance

Conduct root cause analysis and implement corrective actions for non-conformances, ensuring CAPA processes are followed and effectively closed

Develop and maintain standard operating procedures (SOPs) to support and enhance the Quality Management System, ensuring ongoing regulatory compliance

Monitor and manage clean room operations, ensuring adherence to ISO and internal standards for contamination control

Supervise quality technicians, ensuring they are properly trained and follow standardized procedures for inspection and quality control

Lead internal audits, identifying quality issues and ensuring corrective actions are implemented to maintain compliance with internal and external standards

Participate in product validations, ensuring that new products meet quality standards and customer requirements before release

Evaluate new product specifications, ensuring they are aligned with customer requirements and regulatory standards

Generate detailed reports for management meetings, highlighting product quality, risk analysis, customer complaints, and CAPA performance

Support training programs to ensure all employees are knowledgeable about quality procedures, process controls, and CAPA requirements

Ensure full compliance with internal EHS policies, national laws, and industry regulations, maintaining a safe and compliant work environment

Foster a strong focus on product quality assurance, ensuring all products meet specifications and regulatory standards

Other duties as required

Qualification

Six Sigma CertificationInternal ISO Auditor CertificationAdvanced Statistical AnalysisCAPA ProcessesTubing Extrusion ExperienceClean Room ManagementMS Office SuiteEngineering DegreeMedical Device Manufacturing Experience

Required

A degree in Engineering, preferably Mechanical or Industrial Engineering

Six Sigma Certification (desirable) to support process control and quality improvement efforts

Internal ISO Auditor certification (desirable) to lead audits and ensure compliance with ISO standards

Proficiency in MS Office Suite for data analysis, reporting, and documentation

Advanced statistical analysis skills with experience in tools such as Minitab, Gage R&R, Hypothesis Testing, and Design of Experiments (DOE)

Strong experience with CAPA processes, implementing corrective and preventive actions to address quality issues and ensure compliance

Clean Room Management experience, including managing cleaning schedules and contamination control measures

Tubing extrusion experience, with a focus on quality control and process optimization

A minimum of three years of experience in a medical device manufacturing environment, with expertise in product quality assurance and risk management

Company

Spectrum Plastics Group, A DuPont Business

Acquired in August 2023 by DuPont, Spectrum’s history spans over 60 years of applications expertise including precision extrusion, specialty injection molding, blown film extrusion and conversion, medical balloon fabrication, laser processing, additive manufacturing, and complex assembly of catheters and other devices.

Founded in 1961

Alpharetta, Georgia, USA

1001-5000 employees

https://www.spectrumplastics.com/

H1B Sponsorship

Spectrum Plastics Group, A DuPont Business has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

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Trends of Total Sponsorships

2024 (1)