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Quality Systems Engineer II

2 months ago

Irvine, United States Lead Dog Recruiting Full time

I am recruiting for a Quality Systems Engineer II position for a client in the medical device industry in Irvine, CA.


The purpose of this role is to maintain an effective Quality Management System. This role will assist the Quality Manager in the creation of Key Performance Indicators as well as the measurement and monitoring of those KPIs. This role will assist in ensuring compliance to applicable regulatory requirements and internal procedures for Quality Systems such as Internal and External Audits, Corrective and Preventive Action, and Post Market Surveillance and Complaint Trending activities.


Required: Bachelor’s Degree in engineering or related field.


Preferred: CQA, Certified Auditor ISO 13485


A minimum of 5 years work experience in a medical device manufacturing environment in a Quality or Regulatory role is required.

Must be knowledgeable in ISO 13485 requirements.

Must have experience in Complaint investigation and trend analysis.

Must have experience in CAPA Management.

Must have Internal Audit experience and participating in External Audits with regulatory or certification bodies.

Must have experience writing Audit reports, investigation results, creating presentations and charts with summaries and trending analysis.


Must demonstrate understanding and knowledge of:

Complaint and Root Cause Investigation techniques

CAPA Management activities

Audit strategies

Creation of KPIs and trending analysis

ISO 13485 and 21 CFR 820


Must have basic understanding of:

Manufacturing and assembly processes

Medical Device Product Lifecycle

EU MDR requirements

Post Market Surveillance requirements

Statistical Techniques


Other:

Proficient in MS office

Excellent written and communication skills

Would be nice to have experience using IFS and QCBD ERP systems but not required.


If you are interested in further discussing, please submit your resume.

I hope to hear from you.


Jill Dibenedetto

Principal Recruiter

Lead Dog Recruiting

jdibenedetto@leaddogrecruiting.com