Mid to Sr. Design Quality Engineers-Medical Device

Company: Kforce Technology
Location: Carlsbad
Posted on: March 20, 2023

Job Description:

A Kforce client is seeking to hire a Mid to Sr. Design Quality Engineer-Medical Device in Carlsbad, California (CA).



Summary:

The client is a growing and established Medical Device Technology company is seeking a Senior Design Quality Engineer with design controls and risk analysis experience. We are working directly with the Hiring Manager on this exclusive search assignment. The company offers a competitive compensation package including base salary, annual bonus and stock/RSU's.

The Senior Engineer will support Quality Assurance, R&D, Manufacturing Engineering, and Operations in the design and manufacture of disposable medical catheters, in compliance with applicable regulatory and statutory requirements, including but not limited to 21 CFR 820 (Quality System Requirements), EN ISO 13485:2016, EN ISO 14971:2012, and CGMP.



Responsibilities include:

• A Mid to Sr. Design Quality Engineer works during the Design Control and Design Review process through review and approval of the applicable Design Input, Design Output, Design Verification, Validation, and Design Transfer
  
  
• Support R&D, sterilization and assessments, and other quality engineers, documents and assessments, design verification/validation, guide the team to ensure filings are bulletproof and can get approval asap
  
  
• Performs planning, testing, qualifications, and release of design change to released products
  
  
• Performs and/or reviews product acceptance testing; reviews and approves test results; Creates, reviews, and approves device history records
  
  
• Supports activities related to Management Review, CAPA, Nonconforming materials, Process Deviations, Complaints, Product Field Actions, internal and external audits, and related document control functions
  
  
• The Mid to Sr. Quality Engineer is responsible for compliance with quality system procedures and all regulatory requirements
  
  

Keywords: Kforce Technology, San Diego , Mid to Sr. Design Quality Engineers-Medical Device, Engineering , Carlsbad, California