Apply for Quality Engineer - catheter
•Reliability studies •Customer complaints •Customer returns •Field service & repairs
Represent Quality Assurance through all product design and development life cycle phases to help ensure product manufacturability, reliability and cost effectiveness.
Responsible for writing and reviewing Non-Conformance Materials Review to verify discrepancy and adequacy of response to corrective action request.
Create documentation associated with engineering activities including:
•Quality Plans •Test method Verification & validation protocols/ reports •Update Quality System and Department procedures
Participate in product complaint investigations, root-cause analysis, and corrective and preventive actions
Key contributor in Corrective Action and Preventive Action (CAPA) System
Perform Quality System Internal Audits Responsible for Supplier Quality system in monitoring and auditing Requirements: Basic Qualifications:
•B.S. Degree in Mechanical Engineering preferred •Strong skill level in engineering principles (design of experiments, statistical data analysis, tolerance analysis, human factor engineering, FMEA/FTA, reliability, validation, development and execution of protocols/reports •Quality System Regulations knowledge (QSR 21 CFR part 820, ISO 14971, ISO 13485) •Medical Device Design Control knowledge and experience (IEC/UL 60601, MDD, CMDCAS) •Minimum of 5 years of experience in Quality Engineering, Medical Device preferred
•Strong skill level on MS Word, Excel, Access, Power Point, Visio, Experience with Solidworks, CAD • Excellent verbal & written communication skills including presentations (internal & external customers) •Proven ability to interact successfully with all levels of the organization •Must possess high degree of organizational skills and be a self-starter • Ability to work in and contribute to a product development team and other team environments •Ability to plan and prioritize activities •Ability to work independently to meet assigned project deadlines