Validation Quality Engineer (Medical Device)

JOB OVERVIEW

.Prepare and execute validations, technical studies, test method validations and other studies / reports as required.This includes preparation of protocols, establishment of test methodology and acceptance criteria, training personnel, execution, data analysis, investigation, and writing final reports.

.Support site production, operations, and quality and R&D teams by addressing emergent issues that might arise due to the operation processes.Serve as the quality representative during any product or process investigation.Lead investigations including root cause analysis and health risk assessment of the identified product or process nonconformities.

.Prepare and report appropriate metrics to executive management.

.Interface with external auditors (Notified Body, FDA, etc.) during audits at the Monrovia site; participate in the preparation and completion of corrective action plans as needed.

10.Other duties as assigned.

EDUCATION & TRAINING

•A Bachelor of Science (BS) in science or engineering, advanced degree preferred.

EXPERIENCE

•Minimum two year’s experience or advanced degree with one year of experience in quality engineering in the medical device or pharmaceutical industries, including the practical application of FDA Quality System Regulation and ISO 13485 or equivalent. General knowledge of manufacturing processes such as injection molding, assembly, packaging, and sterilization required; experience in the vision care or intraocular lens industry preferred.

SKILLS

•Excellent understanding of quality system regulations applicable to the design, manufacture and global distribution of medical devices or drugs.

•Solid understanding of investigation techniques including design of experiments and root cause analysis.

•Demonstrated understanding and application of Quality System Auditing and Analysis

•Solid grasp of basic statistical techniques with basic understanding of advanced techniques in data analysis.

•Excellent project management, organization, writing and presentation skills required.

•Demonstrated expert knowledge of Windows-based software, including Word, Excel, Access, Project, and Power Point.

•Ability to influence and build consensus across cross-functional groups.

•Must be highly proficient in written and verbal communication.

STAAR Surgical is an equal employment opportunity employer.