Quality Inspector

**ES **S **ENTIAL DUTIES & RESPONSIBILITIES:
- Perform inspections of purchased parts, subassemblies and/or finished company products according to defined criteria in product documentation; drawing, specification, procedures, or build packages. By visual inspection or measurements.
- Competent in all quality processes and procedures according to the training matrix.
- Conduct and document process monitoring audits using documented procedures.
- Accurately document the results of the inspections, monitoring and testing.
- Maintain all controlled document files and test records in a timely and accurate manner.
- Monitor critical equipment and instrumentation to ensure proper calibration.
- Evaluate problems and make initial recommendations for possible corrective action to the area team.
- Identify and communicate defects or suspect materials and initiate the NC (non-conforming) process.
- Work with Production Management to provide feedback to assemblers regarding accuracy of assembly procedures.
- Maintain order and cleanliness of Quality stations and cleanrooms to prevent samples-information mixing.
- The Quality Inspector is responsible to perform the correct completion of inspection results in the DHR (device history Record) all documents. One of the responsibilities of this position is verify and ensure Reconciliation of the data between the documents and the physical quantities, during the process and at the end of each Lot, ensuring the accuracy of records and maintaining supporting documentation.
- Perform review of Device History Records and other documentation for compliance to established procedures and Good Documentation Practices. Other duties or projects as assigned.

**MINIMUM QUALIFICATIONS**:

- High School Diploma or equivalent.
- 2+ year of previous experience as in process inspector.
- One year minimum in Medical Devices Industry.
- Working knowledge of measurement instruments. Knowledge of calibration status. As well as Quality Systems documents such as sampling tables.

**Required Education**:
High School Diploma or equivalent.

**Knowledge, Skills & Abilities (KSA’s)**:
**SKILLS AND ABILITIES**:

- Ability to read and comprehend instructions, short correspondence, and memos in both English and Spanish.
- Ability to interpret drawings with medium degree of complexity.
- Ability to solve practical problems.
- High level of attention to detail.
- Ability to work in a fast paced environment and meet deadlines. Considerable knowledge of inspection methods and procedures, including good manufacturing and good documentation practices.

**COMPUTER SKILLS**:

- Basic knowledge in navigation and use of the Windows operating system in a networked environment.
- Understanding on the use of some Microsoft Office Tools such as: Outlook, Word, Excel, Power Point.

**PHYSICAL DEMANDS**:

- While performing the duties of this job, the employee is regularly required to be stand, walk and use hands and fingers, handle or feel, frequently required to talk or hear, sit, reach with hands and arms, climb or balance, stoop, kneel and crouch.
- Specific vision abilities required by this job include close vision, (vision 20/20 is a plus). If glasses are required to correct vision to 20/20, glasses shall be worn during all inspection activities to ensure visual acuity. The employee must frequently lift and/or move up to 5 pounds, and occasionally lift and/or move up to 20 pounds.

**WORK ENVIRONMENT:
- Ability to work in clean room environment, and use special gown, protection devices for ears and eyes at the same as gloves for hands.