Job Description:

Under broad oversight and in compliance with Company policies and procedures, the QC Lead Inspector, and is tasked with managing the day-to-day operations of the QC department. This position is responsible for QC-related activities, which includes managing workflow, resolving technical challenges identified during the inspection process and communicating and/or escalating said issues to the QC Operations Manager and/or Leadership as necessary.

Major Responsibilities:

1. As the point of contact for the QC area, the Lead Inspector will work closely with Operations and Outside Service Managers to maintain a consistent flow of product throughout the QC department. This includes, but is not limited to, the coordination of product inspection (First Piece, Intermediate, and Final), setting daily priorities, and managing customer service expectations.

2. Responsible for the delegation of work to ensure product throughput expectations are met. Also identifies training requirements and provides training to Inspection personnel as needed.

3. Occasionally performs senior level Inspection, utilizing both basic and complex programmable equipment to measure product dimensions, examine functionality, and compare product to required specifications to ensure said product meets Customer expectations and Company standards-includes First Article, First Piece, Intermediate, and Final Inspection.

4. Supports the operation of CMM and VMM equipment as needed.

5. Assists the Metrology Technician with the gage calibration system to ensure that all inspection equipment as been properly calibrated and is made available when needed.

6. Supports the QC Operations Manager with non-conformances identified both internally and externally via Customer returns, including the investigation of root cause(s) and corrective action as required.

7. Works In conjunction with the QC Operations Manager to analyze processes, work operations, conce88Ions, complaints, returned product, and other sources of quality data in an effort to identify existing and potential causes of nonconforming product.

8. Works independently and/or within a team on speciaVnon-recuning ongoing projects.

9. Support the continuous improvement culture through the Company 6S program and ongoing Lean Initiatives in the QC area.

10. Performs other duties as assigned.

JOB REQUIREMENTS

Education:
High School diploma or equivalent. College degree or Trade School certificate a plus.

Education and Experience:

  • Minimum of three (3) years experience working in a similar Quality supervision related position.
  • Experience working in a highly regulated manufacturing industry a must. Prior exposure to Medical Device industry/working in compliance to ISO 13485 or ISO 9001 a plus.
  • Strong understanding of quality control standards and testing techniques.
  • Ability to clearly communicate with Customers and plant personnel at all levels is essential.
  • Exposure to root cause analysis methods such as 5 why, flahbone, 6M, etc.
  • Able to read and interpret blue prints and specifications. Knowledge of sampling and inspection plans.
  • Working knowledge in reading and comprehending product drawings and GD&T.
  • Familiarity with the utillzatlon of mea,uring Instruments comparator, VMM, micrometer, height gages/electronic height gages, caliper, thread plug gages, and other job-related hand tools.
  • Knowledge of programmable inspection equipment including CMM, VMM, and digital comparators.
  • Understanding of measuring equipment accuracy and measurement system analysis using Gage R&R.
  • Familiar with Good Manufacturing Practices (GMP).
  • Proven record of success working in a fast-paced, high pressure, deadline-driven work environment.
  • Proficiency with various software programs; including MS Office Suite (Word, Excel, PowerPoint).

Physical Demands:

– Required to stand for long periods of time.
– May involve some repetitive motions.
– Must be able to 11ft up to 25 pounds.
– May also engage in frequent bending, stooping, squatting, pushing and pulling.