Quality Engineer Computer Systems Validation in Sturtevant, WI at Volt

Date Posted: 9/26/2018

Job Snapshot

  • Employee Type:
  • Duration:
    48 weeks
  • Date Posted:
  • Job ID:
  • Pay Rate
    $0.0 - $45.0/Hour
  • Contact Name
    Volt Branch

Job Description

Position: Quality Engineer Computer Systems Validation 

Location: Sturtevant, WI

Status: 12-month contract

Volt Workforce Solutions has an immediate opening for a Quality Engineer Computer Systems Validation with our client in Sturtevant, WI. This is a 12 month contract position.

The Quality Engineer Computer Systems Validation will be responsible for executing computer systems validation.  You will participate in and support activities involving compliance with applicable regulatory and Quality Management System requirements. 

Essential Duties and Responsibilities:

  • Execute computer systems validation in accordance with GAMP 5 and 21CFR part 11.
  • Support configuration changes to validated computer systems (SAP, MasterControl Quality Management System, Equipment software etc.).
  • Interface with company IT to address and resolve technical issues that impact validated systems.
  • Assist in development, validation and training on SAP and MasterControl application and other Quality Management System processes.
  • Support risk assessment process for all proposed changes to validated software and operating environments.
  • Work with North America process owners to fully utilize validated software capabilities to enhance their processes.
  • Learn, coordinate, and analyze databases associated with oversight of the Quality System and its reporting process.
  • Support and perform internal and external audit activities, to include pre-audit planning, audit execution and evaluation and post-audit follow up and recommendations.
  • Provide backup in reviewing and approving internal operating procedures.
  • Assist with continued company certification to the appropriate Quality System Standards and Regulations, and assist with all related audits and inspections as required.
  • Assist in ensuring applicability of current quality policies, procedures and objectives by keeping informed of the latest updates/modifications related to ISO quality systems and federal regulations.
  • Provide support within the Quality department and to other North America departments as directed by Quality Assurance Management.

Decision-Making Authority: 

This position has the authority to:

  • Direct and control the efforts of project teams as appropriate.
  • Perform, with minimal supervision, those tasks required to successfully complete assigned projects.
  • Bring to the attention of the Senior Manager, Quality Systems any incident that could negatively impact corporate goals and /or regulatory compliance requirements.

Position Requirements and Competency Measurements

  • Minimum 4 years Computer Systems Validation in Quality Assurance and/or other regulated industry or similar experience.  BS in a Physical Science or Engineering, or equivalent experience.  ASQ Certification as a Quality Engineer or equivalent desirable.
  • Strong organizational, statistical, analytical and problem-solving skills. 
  • Ability to conceptualize, analyze, plan and organize projects. 
  • Knowledge of the corrective action process: failure analysis, problem identification and solution development and implementation. 
  • Ability to work with company staff and communicate effectively throughout the organization is essential. 
  • Experienced in utilizing Quality System Management Software (prior familiarity with MasterControl a plus). 
  • Understanding of ISO 9000/13485 Quality System Standards, FDA Quality System Regulations, GMPs, and/or other international medical device regulations. 
  • Preferred experience in performing internal and/or supplier audits and training of personnel. 
  • Experience in Six Sigma methodology a plus.
  • Some clean room work may be required.  Lifting of light (less than 15 pounds) objects.
  • The physical demands described are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Please apply to position or contact Debbie Linville at 317-599-4893 for any questions and more details regarding this position.

Volt has been serving some of the nation's strongest companies for over 60 years. As a Volt employee, you can expect the highest level of on-site support. We have a long-standing tradition of developing lasting and mutually beneficial relationships with its employees.

Volt is an Equal Opportunity Employer