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Sr. Quality Engineer

  • Location: Greenville, Greenville County, South Carolina
  • Salary: 45-50 per hour
  • Job Type:Contract

Posted 16 days ago

  • Sector: Engineering
  • Start Date: 2021-11-29
  • Job Ref: 21-25373
Schedule Monday Friday standard day time hours

In order to set expectations and to the extent permitted by applicable law, please note that if an applicant is hired for this position, the applicant will be required to prove that the applicant has been fully vaccinated against COVID-19 by the date of hire, subject to any qualified religious or medical exemptions. Please note that the employer reserves its rights to mandate additional vaccine requirements at any time.

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.