Senior Quality Engineer- Birmingham

FloodGate Medical•Tampa, FL

23d•Onsite

About The Position

As a Senior Quality Engineer in Birmingham, AL, you will assist with the development of quality systems, procedures and controls to ensure that all medical products consistently meet performance and quality specifications in the manufacturing facility. The Senior Quality Engineer is a leader and strong technical resource who quickly and effectively resolves quality problems with internal customers and external suppliers. This position reports directly to the Director of Quality Assurance/Regulatory Affairs. The Senior Quality Engineer will play a key role in supporting existing processes for the manufacturing of Rampart radiation shields.

Requirements

A BS degree in manufacturing engineering, quality engineering, life science or related field
A minimum of 5 yrs. experience within the Medical Device Industry.
Candidate must be highly motivated with excellent communication skills and proven ability to work as part of a team.
Quality System Requirements (QSR)
Gage R&R
ISO 13485
IQ/OQ/PQ
CTQ
Production NC
CAPA
Regulatory Requirements
Verification & Validation
Medical devices Engineering change process
Medical Devices Quality Management
Design controls
Problem solving skills

Nice To Haves

Quality Certification
Lead Auditor Certification

Responsibilities

Consistently models the core values of the company both internally and externally.
Openly commit to and support company processes and systems.
Revises / analyzes if the current products and processes (including taken actions or decisions) comply with the regulations, such as QSRs, ISO 13485, etc. including providing support during internal and external audits.
Participates in the preparation’s activities for/or interactions with regulatory agencies (FDA, Interek, etc.)
Actively participate in Management Review & Compliance meetings
Responds to internal or external audit observations related to the quality engineering function.
Properly establishes and maintains the required documentation of quality assurance activities and/or quality systems.
Supervises and supports quality assurance personnel on daily activities.
Performs periodical audits to the line to evaluate GMPs, production controls, lot segregation and process audit.
Checks the audit results of the area to ensure that the corrective and preventive actions are adequate.
Evaluates the need of risk mitigation techniques given product classification, potential types of defects, defect frequency, severity, risk for the patient, process capacity, process controls, etc.
Determines the effectiveness of these techniques in the previously implemented improvements.
Responsible and owner of the risk assessment process including the realization, documentation, revision or maintenance of the current risk and documentation of the risk assessment such as FMEA of the process given the changes in the product/process.
Collate and trend Key performance indicator data
Performs other related duties as assigned to support the efficient operation of the organization.
Carries out additional responsibilities and tasks assigned by management.