The Inspection Specialist position will have an area of excellence that will focus on primary responsibilities e.g. inspection, test, document control, CAPA etc. Each Inspection Specialist will also cross train in other areas of the quality organization to strengthen core competencies as an Inspection Specialist.
Responsible for following Cogmedix’s Quality Management System, cGMP’s and ISO 13485:2016 requirements.
Understands and follows good documentation practices in a cGMP and ISO 13485:2016 environment.
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.
Inspects all incoming products that require Receiving Incoming Inspection to defined inspection criteria, customer drawings, etc.
Inspects manufacturing documentation as outlined in the work order package to verify that it is complete.
Inspects receiving incoming inspection documentation to ensure accuracy and completeness.
Will use various standard and custom measurement and inspection tools and practices including visual, microscopes, torque tools, digital volt meters, vernier calipers, micrometers, and others as needed.
Identifies and reports any product or documentation quality problems or discrepancies.
Ensures products are moved to proper locations as appropriate.
Documents any non-conformances and ensures all product non-conformance paperwork is complete and is included in the work order package.
Maintains proper control of device traceability materials and non-conforming material.
Maintains work area and equipment in a clean and orderly condition and follows prescribed safety regulations.
Performs other activities as directed.
Positive attitude, self-motivator and tenacious follow up required.
Superior customer service attitude.
Strong attention to details.
Excellent teamwork, communication skills, and interpersonal skills.
High School Diploma or equivalent. Further technical training or education preferred.
5+ years’ experience in medical product assembly field, or an equivalent combination of education and experience preferred.
Experience with visual inspection and measurements tools such as microscopes, digital volt meters, vernier calipers, micrometers, preferred.
Basic level skills in MS Word, Excel and databases.
Experience in basic manufacturing environment.
Experience in medical device manufacturing preferred.
Must be able to read, write, and comprehend detailed manufacturing procedures and drawings in English.
A demonstrated commitment to company values.
Excellent manual dexterity and eye/hand coordination