Technician, Quality Engineering

The Quality Engineering Technician works within manufacturing post-market surveillance pre-market Engineering and CAPA in order to perform quality investigations.

- Conduct general research as part of the investigation process.
- Input inspection results data into database tracking systems.
- Maintain investigation files and databases.
- Lead and facilitate investigations.
- Support quality projects and initiatives.
- Learn and maintain knowledge of manufacturing processes and associated documentation.
- Read comprehend and follow product and packaging specifications and manufacturing instructions and drawings.
- Perform data reporting and trending.
- Coordinate manufacture of test samples.
- Coordinate and perform testing to support investigations.
- Must maintain all training requirements for the position while seeking out opportunities for continuous development and growth.
- Adhere to the Quality Management System and its processes to meet FDA 21 CFR 820 ISO 13485 and other applicable regulatory requirements.

- Must work and interact effectively and professionally with and for others throughout various levels of the global organization.
- Must strictly adhere to safety requirements.
- Maintain regular and punctual attendance.
- Must maintain company quality and quantity standards.
- Must have effective communication skills and ability to work in a collaborative and independent work situations and environments with
minimal supervision.
- Ability to remain calm and receptive in fast paced situations.

- High school diploma or GED.
- Associates degree preferred.
- Working knowledge of investigation methods and tools.
- Knowledge of medical device regulations including pertinent standards and guidance preferred.
- Strong organizational skills.
- Critical thinking and attention to detail required.
- Excellent verbal communication skills and technical writing.
- Proficient in Microsoft Word/Excel/Outlook.

Physical Requirements:

General office environment including time in manufacturing environment and biohazard lab
Utilizes close visual acuity for working with computers and equipment
Frequently required to sit stand walk and communicate