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  • Job Title
  • Quality Engineer (medical device)
  • Location
  • Irvine
  • Job Number
  • 114233
  • State
  • California
  • Job Class
  • Full Time
  • Category
  • Engineering
Job Description
Exciting opportunity for an experienced Quality Engineer  to join a growing medical device company in the Irvine area. In this role, you will assist in maintenance of the Quality Management System as well as helping during external audits from the FDA, FDB and Notified Body. May also conduct vendor audits as required. 

DUTIES:

• Initiates DCOs to update, correct and streamline documents in the QMS and for the 
manufacturing process. 
• Suggests, implements projects to streamline product manufacturing and the QMS 
• Works with QC to improve inspections, documentation. Develops workmanships standards for 
the product including development of Work Instructions (CWIs). 
• Works with R&D, Operations, QC, Document Control for overall improvement in product quality 
and manufacturing operations 
• Works with suppliers on resolving non-conformances in raw material components, refining 
specifications, documentation, etc. 
• Manages supplier files including approval, review, re-evaluation etc. 
• Manages non-conforming material reports and makes suggestions for disposition, correction, 
corrective actions, verification of effectiveness, etc.  
• Determines root cause for NCRs, CAPAs, complaints, product failures, etc. 
• Manages CAPA system and makes suggestions for corrective actions, corrections, preventive 
actions, and effectiveness.  Documents and closes CAPAs. 
• Maintains calibration schedule and calibration of equipment.  Controls calibration and manages 
non-conforming equipment. 
• Reports on metrics related to the Quality Management System 
• Initiates, investigates complaints from the company’s products.  Documents initiation, 
complaints, corrective action, if required.  Manages complaint files.  Performs decontamination 
of products. Handles returns on products. 
• Performs DHR review of documentation including label verification prior to final release of 
documentation 
• May perform or assist in design, product, process, sterilization validations, etc. 


WORK ENVIRONMENT
This job operates both in a professional office environment, R&D lab, and cleanroom.  This role routinely 
uses standard office equipment such as computers, phones, photocopiers, filing cabinets, email, etc.  
Work in a cleanroom or laboratory is also part of the position.   


REQUIRED EXPERIENCE 
  • Experience as Quality Engineer in medical devices. (Medical Device start up experience is a plus)
  •  Initiating, implementing, and maintaining a Quality Management System in accordance with ISO 13485, 21 CFR Part 820, and MDD93/42/EEC 
  • Notified Bodies, FDA, Competent Authorities, etc. 
  •  Deciding on substantial changes required notification to regulatory authorities 
  •  eMDRs, and Vigilance Reports 
  • NCR and CAPA closure 

REQUIRED EDUCATION 
Bachelors or Masters degree in Science, Engineering or related discipline. Degree is a MUST
Minimum Five (5) years of related medical device industry experience.

 


 

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