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Quality Engineer

Integrated Resources, Inc Greenville, SC Contractor
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Job Title: Quality Engineer 
Location: Greenville, SC 29611
Duration: 06 Months

 
Job Purpose:
This position is responsible for aspects of process, equipment, facility and computer validation support, ownership of key quality systems supporting daily operations, performance of mandatory quality record review and approvals, and independent continuous improvement projects.

Duties and Responsibilities / Essential Functions:
  • Utilizes standard statistical analysis techniques to evaluate process capability; provides technical guidance and training to other team members in statistical analysis techniques, experimental design, data analysis, sampling techniques and other traditional QA Engineering activities.
  • Participates in site validation and equipment qualification programs; routinely involved with generation, review and/or approval of IQ, OQ, PQ protocols and reports.
  • Supports the CAPA program by working directly with all departments to ensure timely root cause identification for process/product deviations; may organize, facilitate and document Material Review Board activities.
  • Supports quality and operations staff by ensuring effective corrective and preventive actions are identified and implemented.
  • Participates in internal audit programs.
  • Monitors incoming raw material quality, and works with suppliers to improve quality of both delivered products/services and internal quality processes.
  • Works with Quality and Operations management on short and long term quality planning and quality system improvements initiatives.
  • Actively participates in site-wide continuous improvement activities.
  • Drafting new, and revising existing Standard Operating Procedures (SOP)

Minimum Requirements:
Education
  • Prefer BS/BA Degree in Quality Engineering or a related a scientific/technical field (Biology/Chemistry/Engineering)
Other Training
  • ASQ CQE certification preferred
  • Six Sigma and or Lean experience or certification preferred
Experience
  • 2-5 years related experience, working in a regulated environment - working with Pharma or Medical Devices preferred
  • Experience with Quality Inspection techniques
  • Experience conducting independent investigations includes identification of CAPA
  • Experience with Supplier Qualification and Monitoring
  • Experience with Internal Auditing
Skills
  • Demonstrated ability to work effectively and positively with all levels of an organization.
  • Strong written and oral communication skills required.
  • Capable of working both independently and in a team setting; team oriented and committed to continuous improvement.
  • Proficient skills with Microsoft Office (Word, Excel, PowerPoint)
  • Strong organization skills required.Job Title: Quality Engineer 
    Location: Greenville, SC 29611
    Duration: 06 Months

     
    Job Purpose:
    This position is responsible for aspects of process, equipment, facility and computer validation support, ownership of key quality systems supporting daily operations, performance of mandatory quality record review and approvals, and independent continuous improvement projects.

    Duties and Responsibilities / Essential Functions:
  • Utilizes standard statistical analysis techniques to evaluate process capability; provides technical guidance and training to other team members in statistical analysis techniques, experimental design, data analysis, sampling techniques and other traditional QA Engineering activities.
  • Participates in site validation and equipment qualification programs; routinely involved with generation, review and/or approval of IQ, OQ, PQ protocols and reports.
  • Supports the CAPA program by working directly with all departments to ensure timely root cause identification for process/product deviations; may organize, facilitate and document Material Review Board activities.
  • Supports quality and operations staff by ensuring effective corrective and preventive actions are identified and implemented.
  • Participates in internal audit programs.
  • Monitors incoming raw material quality, and works with suppliers to improve quality of both delivered products/services and internal quality processes.
  • Works with Quality and Operations management on short and long term quality planning and quality system improvements initiatives.
  • Actively participates in site-wide continuous improvement activities.
  • Drafting new, and revising existing Standard Operating Procedures (SOP)

  • Minimum Requirements:
    Education
  • Prefer BS/BA Degree in Quality Engineering or a related a scientific/technical field (Biology/Chemistry/Engineering)
  • Other Training
  • ASQ CQE certification preferred
  • Six Sigma and or Lean experience or certification preferred
  • Experience
  • 2-5 years related experience, working in a regulated environment - working with Pharma or Medical Devices preferred
  • Experience with Quality Inspection techniques
  • Experience conducting independent investigations includes identification of CAPA
  • Experience with Supplier Qualification and Monitoring
  • Experience with Internal Auditing
  • Skills
  • Demonstrated ability to work effectively and positively with all levels of an organization.
  • Strong written and oral communication skills required.
  • Capable of working both independently and in a team setting; team oriented and committed to continuous improvement.
  • Proficient skills with Microsoft Office (Word, Excel, PowerPoint)
  • Strong organization skills required.
 

Recommended skills

Corrective And Preventive Actions
Lean Manufacturing
Certified Quality Engineer
Quality Management Systems
(American Society For Quality) Asq Certified
Corrective And Preventive Action (Capa)
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