Quality Inspector Lead

Spectrum Plastics Group•Pleasant Prairie, WI

12d•Onsite

About The Position

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.

Requirements

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.

Responsibilities

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.