Description
Emphasis will be placed on:- Ability to develop, write, implement and train to test / inspection methods of components and Quality System processes
- Provide guidance to Design Control teams in accordance to established procedures
- Maintain and audit DHFs to assure compliance to established procedures and quality system requirements
- Execute trend analysis on Quality Systems for process / product improvement efforts
- Assist (may lead) and effectively document root cause analysis for non-conforming product, CAPA, Complaints, SCARs, NCPs, etc.
- Report on all of the above listed functionality
The Quality Engineer will:
- Be responsible for compliance with applicable policies and procedures
- Develop monitoring systems by identifying critical process steps in processes and/or Quality Systems to capture quality metric data and execute / report trend analysis to lead process and compliance improvements.
- Responsible for ensuring internal/external Quality Systems Requirements are adhered to throughout product and process lifecycles. This includes products in design and development as well as products on market.
- Leads teams through risk based approach for new and/or modified products and processes which includes risk assessment occurs in the appropriate phase of the project, authoring risk management plans and reports, facilitating risk assessment activities with no guidance required.
- Leads and documents root cause investigations related to non-conformities, Complaints, Audits, CAPA, post market surveillance, and product support as required to determine deficiencies in product and manufacturing processes.
- Provides input regarding compliance of design control, risk management, adequacy of testing and processes and production control systems with applicable ISO/EN standards, FDA, QSR, European MDD, and applicable international requirements.
EDUCATION and/or EXPERIENCE
- Bachelor's degree (B.S.) from four-year college or university in science or technical discipline or higher
- The following is preferred but not required:
o 3 or more years Engineering experience in Medical devices
o Medical device Quality experience a plus;
o Class III product experience a plus;
o Proficiency in Solid Works a plus;
o Mechanical Engineer a plus;
o Experience in Global Quality Systems (i.e., ISO13485, QSRs, etc) and Medical Device Regulations (CFR, MDD, SOR, etc) as it relates to department and job duties described within this document.
To find out more about Real please visit www.realstaffing.com