Quality Inspector Lead
Listed on 2026-09-12
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Quality Assurance - QA/QC
Quality Control - QC Analysts/Managers, Production QC/QA, Quality Engineering, Regulatory Compliance Specialist
Spectrum Plastics Group, A DuPont Business |
Spectrum Plastics Group, A DuPont Business | Posted Mar 13
Full-time
Pleasant Prairie
Negotiable
Unknown
We are looking for a Quality Control Lead Inspector to oversee inspection operations in a regulated medical tubing manufacturing environment, with a specific focus on plastic extrusion processes. This role is ideal for a seasoned professional who is not only technically skilled in hands-on inspection and quality practices but also thrives in a leadership role managing tasks, coaching team members, and driving compliance.
The ideal candidate will have a strong working knowledge of ISO 13485, FDA regulations, and Good Manufacturing Practices (GMP). You’ll play a key role in maintaining product integrity and ensuring that our medical-grade tubing meets the highest standards of quality and performance. This is an early level leadership position for those that want to develop supervisory capabilities.
- Ensure all applicable Dupont and Spectrum Plastics Groups Safety Policies are being followed.
- Supervise daily cleanroom inspection activities, ensuring that all in process and final inspections are being completed in a timely manner.
- Perform cleanroom monitoring processes, such as particle counts, collecting bioburden samples, and assist management in handling excursions.
- Review, inspection reports, process documentation, and DHRs for completeness and accuracy
- Participate in root cause analysis and corrective/preventive actions (CAPA) processes.
- Assist in internal and external audits; provide documentation and support as needed.
- Train, mentor, and support quality control inspectors to ensure consistency and competency in inspection methods.
- Provide feedback to QC Supervisor on team performance and improvement opportunities.
- Identify and record any problems relating to the product process and quality system.
- Verify documentation provided by supplier meets the requirements for incoming materials.
- Assist in the control and documentation of nonconforming material, performing special inspections, material segregation, and scrapping activities as required.
- Support implementation of process improvements to reduce defects and scrap.
- Lead by example in promoting quality culture and accountability on the shop floor.
- Ability to read and write in English.
- Capable of carrying up to 40 lbs.
- Able to stand 6-8 hours daily (Ideally 6-12 hours/day).
- Other duties as assigned.
Familiarity with cleanroom protocols and medical-grade manufacturing environments.
Qualifications- High school diploma or equivalent; technical certification or associate degree in a related field is a plus.
- 3+ years of quality inspection experience in a regulated manufacturing environment, preferably medical device or tubing extrusion.
- Proficient in the use of inspection tools and methods relevant to plastic tubing extrusion.
- Strong understanding of ISO 13485, FDA 21 CFR Part 820, and GMP requirements.
- Excellent written and verbal communication skills.
- Strong organizational and task management skills with attention to detail.
- Ability to read and interpret technical drawings and specifications.
- Familiarity with quality systems software and basic data entry.
- Working knowledge of ERP/MES systems (e.g., SAP, Oracle, IQMS).
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