PRIMARY PURPOSE OF POSITION:
Provide quality assurance for all AVS products. Ensure all products are measured using calibrated equipment and are manufactured under controlled conditions, thus ensuring finished devices meet FDA and ISO specifications.
MAJOR DUTIES OF POSITION:
- Ensure that all incoming production materials and components are inspected to approved specifications per the QIPs (Quality Inspection Procedures); label materials as to status, and perform appropriate Syteline transactions.
- Effectively interact with Receiving and Shipping Department to process incoming materials and components accurately and with sufficient dispatch.
- Record results of all in-house testing/inspections on Quality Assurance Worksheets; use the Laboratory Notebook to record details of analyses, observations, sampling preparations, and similar activities.
- Arrange outside chemical/material testing as necessary and ensure that results are within required specifications before releasing to production.
- Support calibration program according to the established schedule and methods, and maintain calibration files (property number, calibration frequency, where equipment is located, calibration procedure number, last calibration date, and next calibration due date).
- Perform environmental monitoring as required by established procedures. On monthly basis, perform sampling of fluid microbes, surface microbes and airborne particles.
- Support shelf-life and process validation studies.
- Prepare samples for sterile load testing.
- Assist with complaint investigations as directed.
- Evaluate and release in-process materials per established procedures.
- Act as back-up to QA Technician II during absences.
- Bring issues to the attention of the QA Manager.
KNOWLEDGE AND SKILL REQUIREMENTS:
- Ability to use all AVS measuring & testing equipment.
- Ability to use a microscope.
- Must be able to work in a cleanroom environment.
- Must have good manual dexterity to handle small, delicate items without inflicting damage.
- Experience in the regulatory requirements of medical device manufacture and complaint processing.
- Proficient in the techniques required for sterility testing, calibration and environmental monitoring.
- Ability to prioritize multiple tasks.
- Strong report writing, organization and documentation skills.
- Prior work experience in quality assurance, preferably in a medical device manufacturing environment.
- Knowledge of GMP (Good Manufacturing Practices) desirable, but not required.
- High school diploma or equivalent, plus one year of training.
Ability to perform all physical demands including standing, kneeling, lifting up to 50 lbs and knowledge and ability to operate lab equipment as needed.