Quality Inspector Lead

Quality Inspector Lead

PPC - Pleasant Prairie - Pleasant Prairie, WI 53158

Overview

Position Type Full Time

Description

We are looking for a Quality Control Lead Inspector to oversee inspection operations in a regulated blown film 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 9001, 22000, 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 who want to develop supervisory capabilities.

• Ensure all applicable DuPont and Spectrum Plastics Groups Safety Policies are being followed.
• Supervise daily production inspection activities, ensuring that all in process and final inspections are being completed in a timely manner.
• Perform environmental monitoring processes, such as particle counts, collecting bioburden samples, and assisting 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 the 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 the 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.

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).

Familiarity with cleanroom protocols and medical-grade manufacturing environments.