Summary of Position with General Responsibilities:|
The ideal Quality Engineering Technician must have experience working in an ISO Certified environment in the Medical device or similar regulated Industry. Provides support to the QA Engineer in development and audit of inspection criteria and methods, technical and statistical investigation on quality problems and complaints, product and process validation and vendor audits.
Essential Job Functions:
Product inspections as per inspection procedures, Drawing or other specifications
- Performs validation protocols, testing, analyzes data and writes reports
- Trains Inspectors and Technicians in:
Product documentation, traceability requirements, acceptance status, and database record keeping
Assures is trained before performing any task
- Monitors compliance to ISO, and QSR and conducts internal and Supplier audits
- Assures proper tools and equipment are available, calibrated and validated fro inspection, test and process monitoring activities of validation activities
- Interprets drawings
- Identifies the appropriate measurement equipment/techniques
- Reviews component Specs and Inspection procedures
Uses the required clothes, personal and security protective equipment according to the requirements of its operation
Complies with the cGMP’s, Quality Standards and established policies and/or procedures
Executes other duties assigned by supervisor
Additional Desirable Qualifications Skills and Knowledge:
- Must be computer literate in Microsoft Word, Excel, Power Point, etc.
- Must follow procedures
- Must possess accurate record keeping of Inspections and Tests Data
- Must be bilingual (English/ Spanish) and must have good communication skills both oral and written
- Team work oriented
Training in basic programming a plus
Bachelor Degree in Engineering or Science desirable
Education and/or Experience:
- Associate Degree in Engineering or Science required
- Must possess a minimum of three (3) to five (5) years experience in a similar position or equivalence in formal Engineering education.
As per Training Matrix.
PHYSICAL REQUIREMENTS AND WORK ENVIRONMENT
1. Frequency and percentage of a day the worker is required to do the following specific types of activities:
% OF A DAY
0-10 lbs. 10-20 lbs. 20-30 lbs. 30-50 lbs. Over 50 lbs.
2a. HAND MANIPULATION REQUIRED? ______Yes (If yes, complete a,b,c,d,e) __X__No
2b. Repetitive hand movements? _____Yes _____No
2c. Simple Grasping?
2d. Power Grasping?
2e. Pushing /Pulling?
2f. Fine manipulation:
C. R. Bard is no upstart in the world of medical devices. The company has been in the business for more than a century and introduced the...