Quality Engineer (16-183) Cameron Health

Tracking Code
16-183
Job Description

DUTIES & RESPONSIBILITIES

- Plans, coordinates, and executes activities concerned with development, application, and maintenance of quality processes and standards for manufacturing processes, materials, and products.
- Interfaces with Operations for nonconforming material disposition.
- Supports quality control activities (including, but not limited to, FMEA, hazard analysis, IQ/OQ/PQ, etc.).
- Supports and initiates standards and methods for inspection, testing, and evaluation of production and product quality conformance.
- Collaborates with Operations personnel in writing and reviewing process validation protocols and reports.
- Creates periodic quality reports supporting quality, operations, and engineering functions.
- Implements internal quality system improvements, audits, and training.
- Develops and initiates sampling procedures and statistical process control methods.
- Develops and initiates methods and instructions for recording, evaluating, and reporting quality data.
- Compiles and writes training material and conducts training sessions on quality control activities.
- Works with product requirements compliance as it relates to manufacturing.
- Expresses data collected in a statistical language; reads and translates statistical data.

Performs other duties and responsibilities, as assigned.
Required Skills

POSITION QUALIFICATION REQUIREMENTS

- BS in Engineering or related field and 3-6 years of quality assurance experience, OR
- MS in Engineering or related field and 0-3 years of quality assurance experience.
- Medical device industry experience is preferred.
- Strong written and verbal communication skills
- Good team work skills with internal and external customers and suppliers
- Understanding of manufacturing processes, challenges, and solutions
- TQM or Six Sigma experience
- Experience with conventional inspection and measurement equipment
- Sound knowledge of Microsoft Word, Microsoft Excel, along with various statistical programs (SPSS, Minitab, JMP)
- Knowledge of ISO standards for Class III medical devices preferable (13485, 14971)
- Quality auditor training preferred.


Required Experience

Previous quality engineering experience in a Class III medical device industry is preferred.

Position Type
Full-Time/Regular.

Location:	San Clemente, CA United States