- Performs testing on subassemblies, final assemblies, and finished medical devices per written specifications e.g., customer specified testing instructions, test records, etc.
- Responsible for following Cogmedix’s Quality Management System, cGMP’s and ISO13485:2003 requirements.
- Understands and follows good documentation practices in a cGMP and ISO 13485:2003 environment.
- Maintains manufacturing documentation as outlined in the work order package and defined by the customer.
- Identifies and reports any product quality problems or discrepancies.
- Documents non-conformances.
- Maintains the work area and equipment in a clean and orderly condition and follows prescribed safety regulations.
- Maintains proper control of device traceability, materials and non-conforming material.
- Performs other activities as directed.
- Positive attitude, self-motivator, tenacious follow up, and superior organization skills.
- Superior customer service attitude.
- Excellent teamwork, communication and interpersonal skills.
- High school diploma or equivalent required. College work or degree a plus.
- Previous work experience in medical device manufacturing a plus.
- 2 years minimum experience in electro-mechanical testing preferred.
- Must be able to read, write, and understand concepts and detailed instructions, test procedures, and records in English.
- Familiarity with hi-pot testing, ground bond testing, electrical safety testing, use of DMM, etc.
- Working knowledge of computers, including Microsoft Office (Word and Excel) and ability to load software and manage different test applications.
- Very detail oriented, strong commitment to quality and a high degree of accuracy.
- Able to understand basic manufacturing methods.
- A demonstrated commitment to company values.
- Excellent manual dexterity and eye/hand coordination
- Standing for prolonged periods of time
- Sitting for prolonged periods of time
- Ability to lift up to 30 lbs