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Quality Engineer

3 months ago

Covington, United States MILLENNIUMSOFT Full time

Job Title: Quality Engineer (Must Have Project management skills with FDA knowledge)

Location: Covington, GA

Contract Term: 5+ Months

Weekly 40.00 Hours [Mon - Fri]

1st Shift

Ideal Candidate would possess project management skills along with FDA guidance knowledge. Candidate must be able to lead cross functional team meetings and work with different sites to ordinate the efforts on the project. In-depth knowledge on requirements and risk management process is highly recommended.

Description:

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. 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). 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. Working knowledge of statistical methods as well as statistical application software. Effective verbal and written communication skills. The ability to work in teams and independently with minimal supervision to obtain results as required. Must be self-motivated/directed, organized, detail oriented and have ability to multi-task projects. Professional certification is an advantage (i.e. CQA, CQE, SQE, CQM, Six Sigma, etc.).

To perform this job successful, an individual must be able to perform each essential duty satisfactorily. The requirements listed in this section and below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• 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.
• Experience in writing process, software, and equipment protocols/validations and has fundamental knowledge of validation principles.
• Ability to participate on teams and maintain positive work environment with those teams.
• Good communication skills (verbal, written, and presentation)
• Understands Basic Fundamentals of Engineering Principles
• Ability to effectively manage time
• Ability to handle multiple task assignments.
• Ability to translate quality requirements into product specifications.
• Ability to interpret Regulations, Corporate, Division and Department Procedures.