QLTY & RELIABILITY ENGINEER I
Job Overview
What your background should look like:
EXPERIENCE & EDUCATIONAL REQUIREMENTS:
- 0-1 year of experience in a Quality Technician V position. Quality leadership experience working in a manufacturing environment, ideally in a multi-national environment.
- Bachelor’s Degree with a scientific or engineering emphasis.
Professional Training & Certifications:
CQE/CSSBB certification desirable.
Job Specific Knowledge, Skills and Abilities:
- Knowledge - NCMRs/CARs/CAPA, Customer Complaints per million, Quantity of returned product (RMAs), DPPM, DLPM.
- Skills are the proficiency to perform a certain task.
- Abilities are an underlying, enduring trait useful for performing tasks (oral comprehension, understanding information and ideas).
- English Intermediate.
- Knowledge of Microsoft Office.
- Knowledge of problem-solving techniques.
- Knowledge of working requirements in the medical industry (FDA regulations).
- Excellent knowledge of Creganna Quality System.
- Knowledge of statistical tools, quality and reliability software.
- Knowledge of spreadsheets, databases, and Process Control Monitoring (SPC).
- Experience in process improvement, Six Sigma, product and process qualification and validation.
- Detailed knowledge of FDA, GMP and ISO 13485.
- Experience in new product transfer.
- Knowledge of measuring instruments, sampling plans.
Competencies
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Job Segment:
Business Process, Six Sigma, Testing, Manufacturing Engineer, QC, Management, Technology, Engineering, Quality