Demo

Production Quality Controller

Katalyst HealthCares and Life Sciences
West Chester, PA Full Time
POSTED ON 2/17/2025
AVAILABLE BEFORE 5/17/2025

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 Machinist / Programmer 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.
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