· Support site production, operations, and quality teams
Initiate and lead change assessments and impact assessments
TASKS
· Support site production, operations, and quality teams by addressing emergent issues that might arise due to the operation processes. Serve as the quality representative during product or process investigation. Lead investigations including root cause analysis and risk assessment of the identified product or process nonconformities.
· Prepare and execute equipment validations and qualifications, 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.
· Initiate and lead assessments and impact assessments. Handle any deviations to close validation documentation
· Other duties as assigned.
Education: A Bachelor’s degree in quality, mechanical, life sciences or industrial engineering
Special Knowledge: Solid understanding of quality system regulations applicable to the manufacture and global distribution of medical devices or drugs.
Solid understanding of investigation techniques including design of experiments and root cause analysis.
Understanding and application of Quality System Auditing and Analysis
Solid grasp of basic statistical techniques with basic understanding of advanced techniques in data analysis.
Good English skills, both written and spoken
Project management, organization, writing skills required.
Demonstrated expert knowledge of Windows-based software, including Word, Excel, Access, Project, and Power Point.
Knowledge of the Software Kneat is a plus
Knowledge of the Kaye Validator System is a plus
Personality: Ability to influence and build consensus across cross-functional groups.
Must be highly proficient in written and verbal communication.
Professional Experience: Minimum two years’ 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. For Senior Position: Minimum five years’ experience or advanced degree with three years of experience.
General knowledge of manufacturing processes such as tumbling, hydration, depyrogenation, saturation. Experience in the vision care or intraocular lens industry preferred.