Quality Systems Engineer II (TAS)

Terumo•Davie, FL

4d•Onsite

About The Position

Responsible for supporting the quality engineering systems related with updating and implementing SAP/HANA. Provides technical support to the maintenance and improvement of the quality systems. Develops quality standards and controls. Develops product, process and systems qualification protocols for new systems and existing manufacturing production lines. Advises company management on quality assurance requirements. Review non-conformance reports along with product risk assessment and performs root cause investigations.

Requirements

Bachelor’s degree in a technical discipline, or equivalent, with 3+ of experience in medical device quality assurance.
Experience with class III cardiovascular medical devices
Thorough understanding of quality system regulations (e.g. 21CFR820, ISO 13485)
Excellent Written and Verbal Communication
Understanding of quality system regulations (ISO13485, 21CFR820)
Understanding of Computerized System Validation requirements for Medical Devices (21CFR Part 11).
Ability to interact with all levels within organization.
Analytical skills for compiling and analysing data.
Mechanically inclined
Computer and software skills
Ability to motivate others and work independently.

Nice To Haves

Knowledge of DOE, SPC, Gage R&R, and sampling plans

Responsibilities

Quality engineering, system and process validation, project team leadership and participation, document generation and control, data analysis, corrective and preventive action.
Prepares and implements quality standards, operating procedures, inspection and test procedures and reporting systems.
Being responsible for approving corrective and preventive action plans, implementation of required activities and objective evidence and effectiveness verification
Supports CAPA and auditing programs and performs assigned actions to address quality issues.
Leads CAPA Monthly meetings and organizes stewardship reviews of CAPA documentation
Establishes and maintains CAPA metrics
Reviewing content of CAPA root cause investigations, corrective actions, effectiveness criteria and compliance to regulatory and procedural requirements
Interacts with cross-functional teams to obtain system requirements and feedback to implement preventive and/or corrective actions.
Reports and presents status of assigned projects to the management team. Identifies areas of risk and recommends mitigation actions.
Prepares and implements proposals for improvement to the quality management system. Provides follow-up actions as necessary.
Develops quality plans, validation plans, risk assessments and other validation related deliverables for the implementation of electronic quality management systems.
Ensures quality system compliance for areas of responsibility.
Reviews, approves changes under the change management system, as required.
Initiate investigations and product performance risk analysis for nonconforming products and the quality management system.