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Quality Engineer II

Company:
Lancesoft Inc.
Location:
Irvine, California, United States
Posted:
March 22, 2019

Description:

Description:

Responsible for development, implementation of product issue escalation and field action procedures and support any department projects for the improvement of the product escalation, Risk Management Board (RMB), Quality Review Board (QRB) and Field Action processes

ESSENTIAL DUTIES AND RESPONSIBILITIES:

The individual will work under limited supervision in the following:

1. Execute, monitor, report and drive results in the implementation of the Product Issue and Field Action processes in accordance with J&J and external regulatory requirements

2. Make compliance decisions to meet internal/external customer needs.

3. Coordinate Risk Management Board, Quality Review Board (QRB) and Field Action activities per the established Customer Standards and procedures.

4. If needed, this individual will be responsible for reporting & presenting to management quality system metrics and status in appropriate Quality Systems review boards such as Management Review, CAPA Review Board, Q&C Dashboard, etc.

• Other responsibilities include, to facilitate root cause investigation, documentation, corrective action recommendations, and project management on issue escalation and field action processes; provide periodic reports, completes special assignments, assists manager as requested; and lead and participate in cross-franchise teams as directed by manager

REQUIRED EDUCATION/TRAINING and/or EXPERIENCE:

• Bachelor of Art or Science Degree in Science Field is required. Minimum of 4 years in medical device manufacturing or related industry experience is required.

REQUIRED KNOWLEDGE, SKILLS, ABILITIES and CERTIFICATIONS/LICENSES:

• Prior experience in ISO 13485 and or QSR 820 FDA regulated environment, and project management is desired. Excellent interpersonal relations and communication skills are required. Advanced skills on Microsoft Office software, including PowerPoint, is required.