Production Quality Controller
Katalyst HealthCares and Life Sciences - West Chester, PA
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Responsibilities: Perform First Article Inspections, (FAI's) for the Cell. FAI's must be performed in a timely manner throughout the day. No open FAIs are to remain at the end of the shift. Responsible for writing inspection plans for manufacturing cells for input into proprietary inspection software. Work with Management to develop specific and measurable goals, improvements and standards to continuously and consistently improve quality and reduce errors. Act on behalf of the customer to audit and maintain the accuracy and timely delivery of products. Make sure that roving inspections are done at all workstations on a routine daily basis and results are reported back to the machinist and cell Manager. Assisting in maintaining ISO 9001 and 13485 Medical Device Quality Management System compliance. Inspect materials, products, and equipment to find defects and implement corrections. Lead by example in performing FAI's and roving inspections. Generate Non-Conforming Reports, (Client's), to notify employees of production errors. Make certain that those involved are trained to avoid a repetition of previous mistakes. Assists in the maintenance and calibration and traceability of gages and other inspection equipment. Maintain the compliance and accuracy of all data entered system. Control, maintain and keep an accurate inventory of all Inspection equipment. Observe work, and monitor measurements, data, and other indicators to ensure operators comply with processing standards. Assist employees with the interpretation of blueprints and with the analysis of parts according to those prints. Notify employees of quality related errors and how they can be corrected. Train new employees in the inspection software. Ensures that all Trainings assigned to employees in the cell are completed in a timely manner. Train new employees in the efficient and proper use of inspection tools and machines, including but not limited to, calipers, gauges, micrometers, and comparators. Guide new employees through the inspection process. Requirements: Must be comfortable in leading and enforcing rules and regulations associated with ISO 9001 and 13485 Medical Device Quality Management System within your team. Degree in Metrology or related. CNC MachinistProgrammer background. Experience working in a manufacturing facility that produces orthopedic implants, aerospace components, or other precision machined related industries. Must be able to lead and mentor a team of machinists. Excellent attention to detail and ability to multi-task. Motivated self-starter. 100% Employer Paid Medical Benefits. Dental Vision Benefits. Work-Life Services Benefit Program (Employee + Family). Group Life Insurance. 401k retirement plan with employer match. Personal Time Off (PTO). Over Time. Holiday Pay. Relocation Assistance. Professional Development. 100% Paid Uniforms.
Created: 2025-02-20