Production Quality Controller/Team Leader

What You Will Do

• 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, (NCR’s), to notify employees of production errors. Make certain that those involved are trained so as 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 into 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 on the inspection software.
• Ensures that all Trainings assigned to employees in the cell are completed in a timely manner.
• Train new employees on 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.

Who You Are

Must Haves:

• Must be comfortable in leading and enforcing rules and regulations associated with ISO 9001 and 13485 Medical Device Quality Management System within your team.

Preferred

• Degree in Metrology or related.
• CNC Machinist/Programmer background.
• Experience working in a manufacturing facility that produces orthopedic implants, aerospace components, or other precision machined related industries.