What are the responsibilities and job description for the Technician, Quality position at Ambu?
Objective:
Perform a variety of functions to support the USNV overall Quality Management Systems (QMS). Assisting the Quality department with improvement initiatives and supporting projects/activities associated with key QMS systems including, but not limited to, calibration process, NCRs, CAPAs, training, document control, and testing.
Responsibilities and Essential Functions:
- Perform calibration of a wide variety of instruments used for inspections and production of medical devices.
- Perform troubleshooting of out of tolerance instruments and collaborates with engineering and tool room to make necessary repairs to bring instruments back into working order and required tolerance.
- Complete required documentation in accordance with established procedures.
- Assist Calibration Coordinator with preparing instruments to be sent to outside vendor for calibration.
- Assist Calibration Coordinator with the creation of calibration procedures.
- Assist with proper filing and organization of calibration files.
- Create and submit purchase orders associated with calibrations activities.
- Assist with training personnel on calibrated equipment in manufacturing.
- Assist Calibration Coordinator with conducting periodic audits of calibrated instruments and records.
- Assist with receiving and escorting outside vendors onsite.
- Develop and executes programs in the Coordinate Measuring Machine (CMM).
- Assist with the traceability of calibrated instruments on the floor.
- Assist Quality Engineering (QE) with NCRs, and CAPAs activities.
- Support QE with the implementation of change under the change control process.
- Assist with data collection, mining, and analysis.
- Assist with disinfection/cleaning of complaint sample returns.
- Perform laboratory testing and inspections associated with validation protocols and engineering studies.
- Support training activities associated with changes impacting QA personnel on the floor.
- Maintain training curricula status up to date within established grace period.
- Perform special projects and all other duties as assigned.
Required skills:
- Good attention to detail and organizational skills.
- Ability to read inspection gauges/instruments (e.g., tape measure, Go/NoGo gauges, calipers, etc.) and other measuring devices.
- Ability to read and understand part drawings.
- Ability to follow directions and documented instructions.
- Ability to work independently in accordance with specifications and procedures.
- Ability to work well with others and communicate effectively.
- Ability to work weekends or off hours, if necessary.
- Proficiency with Microsoft Office (Word, Excel, PowerPoint).
- Must be able to read, write and understand English.
Preferred skills:
- Experience with programming and operating CMMs (e.g., Zeiss, Hexagon, Mitutoyo).
- Experience with calibration of temperature controllers (On/Off, proportional, PID) and temperature sensors (thermocouples and RTDs).
- Ability to read and understand electrical schematics.
Work Environment:
This is a manufacturing facility and as a result, employees have the potential to be exposed to noise, chemicals, fumes, airborne particles, machinery, vibration, or other workplace hazards controlled within compliance of current safety and health standards.
Qualifications:
- High school diploma or GED equivalent
- Basic knowledge of Calibration practices
- Experience in medical device industry preferred
- Must be able to speak, read, write and understand English
Job Type: Full-time