Supplier Quality Engineer


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Irvine, CA

Posted on 12/7/2017


Job Overview

Company:
Ultimate
Location:
Irvine, CA
Contact Person:
Nicole Phillips
Phone:
949-250-3511
Employment Type:
Contractor
Application Deadline:
1/6/2018
Relocation Covered:
Yes

Job Description

SUMMARY:
This is an in-house position focused on remediation of supplier files focused on compliance.

ROLE PURPOSE:
Applies knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and Edwards' systems/procedures to optimize product development, internal and external device manufacturing, and device distribution.

ESSENTIAL JOB FUNCTIONS:
• Lead in the investigation of complex manufacturing product quality and compliance issues (e.g., CAPA, non-conformances, audit observations) for all production processes based on engineering principles; analyze results, make recommendations and develop reports
• Drive the development and manage the execution of complex experiments and tests (including writing and executing protocols) to create, validate, and improve products (including evaluation of source materials and suppliers) and manufacturing processes/methods based on engineering principles; analyze results, make recommendations, and develop reports and collaborate with team members to drive project completion
• Lead in the identification and ensure the optimization of complex Manufacturing processes using engineering methods (e.g., SIX Sigma and LEAN methods) for design for manufacturing and for continuous process improvement.  Identify opportunities for re-design/design of more complex equipment, tools, fixtures, etc. to improve manufacturing processes, and reduce risk.
• Develop technical content of risk management files
• Develop training and documentation materials for production (e.g., work instructions) to enable the seamless knowledge transfer of project and manufacturing processes
• Oversee Quality support tasks; gives instruction to engineers/technicians on conducting tests; trains engineers/ technicians and provides feedback; and may coordinate engineers/ technician work.
• Train, coach, and guide lower level employees on more complex procedures

QUALIFICATIONS:
• Bachelor's degree in Engineering required
• 3+ years of related experience required
• ASQ Certified Quality Engineer (CQE) preferred
• Extensive knowledge and understanding and knowledge of principles, theories, and concepts relevant to Quality Engineering (e.g., CQE body of knowledge)
• Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills
• Knowledge of Six Sigma concepts with ability to apply to work product
• Knowledge of Quality Engineering concepts with ability to apply to work product
• Advanced problem-solving, organizational, analytical and critical thinking skills
• Extensive understanding of processes and equipment used in assigned work
• Strong leadership skills and ability to influence change
• Knowledge of and adherence to the company's Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing
• Strict attention to detail
• Proven expertise in statistical techniques
• Proven expertise in usage of MS Office Suite
• Ability to read and interpret drawings

 

We are an equal opportunity employer.QUALIFICATIONS:
Bachelor's degree in Engineering required
4+ years of related experience required
ASQ Certified Quality Engineer (CQE) preferred
Extensive knowledge and understanding and knowledge of principles, theories, and concepts relevant to Quality Engineering (e.g., CQE body of knowledge)
Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills
Knowledge of Six Sigma concepts with ability to apply to work product
Knowledge of Quality Engineering concepts with ability to apply to work product
Advanced problem-solving, organizational, analytical and critical thinking skills
Extensive understanding of processes and equipment used in assigned work
Strong leadership skills and ability to influence change
Knowledge of and adherence to the company's Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing
Strict attention to detail
Proven expertise in statistical techniques
Proven expertise in usage of MS Office Suite
Ability to read and interpret drawings

Apply Now