Overview
Quality Assurance Engineer Jobs in Irvine, California, USA at Katalyst CRO
Responsibilities
This position has primary responsibility for the investigation, review, and completion of all Quality Engineering complaint issue analysis tasks utilizing various quality system inputs.
Review individual complaints and associated service data to determine risk level and complete investigation into the “as determined” problem code and cause codes for each complaint.
Analyze data from various quality inputs (including but not limited to:
Field Corrective Action (FCA), Complaints, FDA Medical Device Reports (MDR), etc.) to determine trends and systemic issues. Prepare and issue reports based on information analysis.
Review existing investigation reports and identify gaps for GMP compliance. Develop strategies and plans to close the gaps in an efficient and technical manner.
Develop and communicate expectations for quality performance, continuous improvement, and process controls for marketed products.
Monitor and drive corrective action and continuous improvement activities that directly impact performance measures by performing primary investigations, conducting data analysis, and implementing corrective actions.
Conduct or lead corrective and preventive actions in manufacturing using formal problem-solving tools and documentation.
Support CAPA and maintenance activities for existing product lines.
Recommend and/or support projects for improvements to the quality system as approved by management.
Requirements:
A Bachelor of Science degree in Engineering.
1-3 years of Medical Device experience.
Medical Device
Experience with knowledge of 21
CFR
820 preferred.
Investigational research skills.
Experience with any statistical software packages (Minitab a plus).
Desired experience in the medical device industry in the development and deployment of Quality Systems, process controls, and continuous improvement methods.
Knowledge and working application of FDA cGMP; ANSI/ISO/ASQC requirements; CMDAS (optional).
Knowledge and working application of reading and understanding blueprints and technical drawings.
Demonstrated strong analytical problem-solving (Root Cause Investigations).
Display a solid technical understanding of engineering principles and procedures (e.g., CAD and its application or scheduling a series of technical tasks utilizing software-based tools).
Computer competency in Word, Excel, PowerPoint, Minitab, Access, and databases.
Ability to multi-task and methodically manage projects.
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Title: Quality Assurance Engineer
Company: Katalyst CRO
Location: Irvine, California, USA
Category: Engineering (Quality Engineering), Quality Assurance – QA/QC (Quality Engineering)
