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.