1. As a member of the quality organization, the Inspection Specialist III will ensure that all Work In Process (WIP) quality checks for each medical device are compliant to all applicable specifications.  The Inspection Specialist III will be directly responsible for the acceptance of final medical device and issuance of the Certificate of Conformance. The Inspection Specialist III trains Inspection Specialist II and Inspection Specialist I, as needed.

Roles & Responsibilities:

      1. The Inspection Specialist III position will have an area of excellence that will focus on primary responsibilities e.g. inspection, test, RII, SME, Trainer, etc.  Inspection Specialist III will cross train in other areas of the quality organization to strengthen core competencies as an Inspection Specialist III.
      2. Inspects components, sub-assemblies, final assemblies, and finished medical devices per written specifications including defined inspection criteria, work instructions, work order routings, customer drawings, etc.
      3. Floor mentor sharing the understanding of the inspector’s role and relevance in meeting the company’s quality policy and objectives.
      4. Advanced ability to perform multiple types of inspections: In Process, Final QC, Source, Electro-mechanical, and Cable & Harness.
      5. Advanced knowledge of inspection reporting.  Documents any non-conformances, ensures all product non-conformance paperwork is complete, and is included in the work order package.
      6. Advanced knowledge how to identify non-conforming material properly and reports any product or documentation quality problems or discrepancies.
      7. Maintains proper control of device traceability materials and non-conforming material.
      8. Strong attention to detail.
      9. Ability to work with a sense of urgency without compromising quality
      10.  Exceptional mechanical aptitude and mathematical skills.
      11. Trains Quality Inspection Specialist II and Inspection Specialist I that will focus on primary responsibilities e.g. inspection, test, document control, etc.
      12. Advanced knowledge working with various standard and custom measurement and inspection tools and practices including visual, microscopes, torque tools, digital voltmeters, Vernier calipers, micrometers, and others as needed.  Provides guidance on proper techniques.
      13. Floor mentor following Cogmedix’s Quality Management System, good documentation practices, cGMP’s and ISO 13485 requirements.
      14. Advanced knowledge of working with assembly blueprints, bills of materials, etc.  Review manufacturing documentation as outlined in the work order package to verify that it is complete.  Provides guidance on proper techniques.
      15. Advanced knowledge with GD&T symbols on drawings.  Provides guidance to other associates on performing measurements with GDT&T symbols.
      16. Inspect PCBA’s to IPC-A-610 standard and wires and cables to IPC-A-620 standard.
      17. Inspects all incoming products that require Receiving Incoming Inspection to defined inspection criteria, customer drawings, etc.
      18. Will work with customer during Co-builds to learn inspection requirements and transfer that knowledge to other Quality Inspection Specialists.
      19. Maintains work area and equipment in a clean and orderly condition and follows prescribed safety regulations.
      20. Able to work with effectively with direct supervision.
      21. Performs other activities as directed.

Essential Requirements:

    1. Positive attitude, self-motivator and tenacious follow up required.
    2. Superior customer service attitude.
    3. Strong attention to details.
    4. Excellent teamwork, strong communication skills, and interpersonal skills.
    5. High School Diploma or equivalent.  Further technical training or education preferred.
    6. 10+ years’ experience in medical product Inspection field or an equivalent combination of education and experience preferred.
    7. Advanced experience with visual inspection and measurements tools such as microscopes, digital voltmeters, Vernier calipers, micrometers, preferred.
    8. Intermediate to advanced level skills in MS Word, Excel and databases.
    9. Experience in manufacturing environment.
    10. 5+ years’ experience in medical device manufacturing.
    11. Must be able to read, write, and comprehend detailed manufacturing procedures and drawings in English.
    12. A demonstrated commitment to company values.
    13. Physical requirements
      1. Excellent manual dexterity and eye/hand coordination.
      2. Standing for prolonged periods of time.
      3. Sitting for prolonged periods of time.
      4. Ability to lift up to 30 lbs.
    14. Certified Quality Inspector required.