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Quality Engineer

Carlsbad , CA


 

 

Required Skills, Training, and Experience to Perform the Essential Functions:


  • Bachelors and/or advanced degree in a science or technical area or equivalent

  • 5 - 8 years industrial experience, preferably in high volume injection molding, automation and quality principles within medical device industry with demonstrable skills in project management, critical path analysis, injection molding theory, equipment, tooling, materials, assembly and/or processing

  • Medical device experience preferred

  • Strong fundamental understanding of FDA CFR 21 or ISO 13485 requirements

  • A CQE is preferred but not required.

  • Strong leadership with adept communication

  • Skilled at analyzing data and summarizing.


 

Essential Duties and Responsibilities:


  • Establish and direct the project team regarding Quality requirements; to provide the most efficient end to end project implementation from part concept through first production order including assembly transfer, if applicable

  • Directs quality assurance activities for all current and future medical/commercial products.

  • Enacts and manages Quality elements of transfer to manufacturing to include formal documentation and implementation of process flow, risk analysis (PFMEA), control plans, inspection plans, measurement fixtures, and measurement equipment.

  • Enacts and manages Master Validation activities, including IQ, OQ, PQ; measurement system analysis, gage R&R, and measurement correlation.

  • Provides Statistical Analysis for the associated quality activities and assist in Metrology activities

  • Establish and update Quality Systems based on changes to pertinent regulations, audit observations and changes to existing products and processes.

  • Manage and perform activities associated with CAPA, SCAPA, Supplier Quality, Complaints, Non-Conforming Materials, Inspection and Calibration.

  • Provide assistance to Manufacturing on continuous improvement opportunities

  • Propose regulatory strategy for new and modified products

  • Weekly/monthly reporting (local and corporate teams)

  • Develop and establish SOP's according to regulatory requirements

  • Oversee qualification and management of overall Supplier base

  • Lead and facilitate Kaizen teams

  • Lead others in the quality department through implementation and maintenance of the company quality system, reporting on the performance of the quality system for review and as a basis for improvement of the quality system.

  • Direct contact with customers, supplier’s management, authorities, and sister organizations functional groups

  • Facilitates and Manages project team members including Engineering staff and Quality Associates to insure successful completion of projects.

  • Other assignments as necessary


 

 

Education/Experience:


  • Bachelors and/or advanced degree in a science or technical area or equivalent

  • 5 - 8 years’ industrial experience, preferably in high volume injection molding, automation and quality principles within medical device industry with demonstrable skills in injection molding theory, equipment, tooling, materials, assembly and/or processing

  • 4-7 years related experience and/or training; or equivalent combination of education and experience.

  • Knowledge of Lean Six Sigma, Lean Manufacturing principles, minimizing 8 wastes and tools

  • CAD experience in 3D Modeling preferably Solidworks.

  • Understanding of the requirements specified by the FDA, OSHA, ISO, QS, governmental agencies, and the Healthcare Industry


 

Language Ability:

Ability to read and write in English; secondary language skill are desirable but not required.

Computer Skills:


  • Microsoft office skills

  • ERP/MRP systems

  • Engineering software – Solidworks or equivalent, MiniTab


 

Certificates and Licenses:

Lean Six Sigma Green Belt certification preferred.

Lean Six Sigma Black Belt certification a plus
Job: 5741



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