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Quality Engineer 2

In Georgia / United States

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Quality Engineer 2   

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JOB TITLE:
Quality Engineer 2
JOB TYPE:

JOB SKILLS:
JOB LOCATION:
Covington Georgia / United States

JOB DESCRIPTION :

Roles and Responsibilities:-

  • Responsible for reviewing and assessing Quality Notifications, Complaints, Deviation/Waivers and other cGMP activities for the assigned product lines in the instrument plant.
  • Oversee operations and assure documentation and procedures are followed, updated and maintained as required by internal Quality Policies and related FDA/GMP guidelines.
  • Conducts complaint investigations, assists in the investigation of manufacturing issues and provides data and input on technical issues and projects.
  • Proven ability to develop solutions to a variety of problems of moderate scope and complexity, using policies and procedures for guidance. Capable of using Microsoft programs and ability to learn other systems.
  • Ability to perform detailed engineering work under direction of a Senior Engineer or Quality Management. May require consultation and direction to complete the essential duties and responsibilities.
  • Understands basic applied statistics.
  • Knowledge of manufacturing processes
  • Comprehensive knowledge of quality systems and relationship to business.
  • Ability to participate on teams and maintain positive work environment with those teams.
  • Understands Basic Fundamentals of Engineering Principles
  • Ability to translate quality requirements into product specifications.
  • Ability to interpret Regulations, Corporate, Division and Department Procedures.
  • The ability to work in teams and independently with minimal supervision to obtain results as required.

Education and Experience:-

  • BS or BA in related field required with 4 years of experience, or MS with 3 years of experience required (project management experience preferred).
  • Typical degree in Mechanical or Electrical or Industrial Engineering, Biological Sciences, Chemistry, and/or Computer Science or other related field.
  • Must demonstrate a working understanding of the pertinent Quality Systems Regulations (i.e.: Good Manufacturing Practices, ISO, FDA).
  • Professional certification is an advantage (i.e. CQA, CQE, SQE, CQM, Six Sigma, etc.).
  • Experience in writing process, software, and equipment protocols/validations and has fundamental knowledge of validation principles.

Skills:-

  • Effective verbal and written communication skills.
  • Must be self-motivated/directed, organized, detail oriented and have ability to multi-task projects.
  • Working knowledge of statistical methods as well as statistical application software.
  • Good communication skills (verbal, written, and presentation)
  • Ability to effectively manage time
  • Ability to handle multiple task assignments.

Position Details

Apr 11, 2021
S16174661695193741
Georgia / United States
Covington
A job sourcing event
In Dallas Fort Worth
Aug 19, 2017 9am-6pm
All job seekers welcome!

Quality Engineer 2    Apply

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Roles and Responsibilities:-

  • Responsible for reviewing and assessing Quality Notifications, Complaints, Deviation/Waivers and other cGMP activities for the assigned product lines in the instrument plant.
  • Oversee operations and assure documentation and procedures are followed, updated and maintained as required by internal Quality Policies and related FDA/GMP guidelines.
  • Conducts complaint investigations, assists in the investigation of manufacturing issues and provides data and input on technical issues and projects.
  • Proven ability to develop solutions to a variety of problems of moderate scope and complexity, using policies and procedures for guidance. Capable of using Microsoft programs and ability to learn other systems.
  • Ability to perform detailed engineering work under direction of a Senior Engineer or Quality Management. May require consultation and direction to complete the essential duties and responsibilities.
  • Understands basic applied statistics.
  • Knowledge of manufacturing processes
  • Comprehensive knowledge of quality systems and relationship to business.
  • Ability to participate on teams and maintain positive work environment with those teams.
  • Understands Basic Fundamentals of Engineering Principles
  • Ability to translate quality requirements into product specifications.
  • Ability to interpret Regulations, Corporate, Division and Department Procedures.
  • The ability to work in teams and independently with minimal supervision to obtain results as required.

Education and Experience:-

  • BS or BA in related field required with 4 years of experience, or MS with 3 years of experience required (project management experience preferred).
  • Typical degree in Mechanical or Electrical or Industrial Engineering, Biological Sciences, Chemistry, and/or Computer Science or other related field.
  • Must demonstrate a working understanding of the pertinent Quality Systems Regulations (i.e.: Good Manufacturing Practices, ISO, FDA).
  • Professional certification is an advantage (i.e. CQA, CQE, SQE, CQM, Six Sigma, etc.).
  • Experience in writing process, software, and equipment protocols/validations and has fundamental knowledge of validation principles.

Skills:-

  • Effective verbal and written communication skills.
  • Must be self-motivated/directed, organized, detail oriented and have ability to multi-task projects.
  • Working knowledge of statistical methods as well as statistical application software.
  • Good communication skills (verbal, written, and presentation)
  • Ability to effectively manage time
  • Ability to handle multiple task assignments.