Engineer III, QA

at  Thermo Fisher Scientific

EDUCATION:

Minimum: Bachelor of Science (BS) in a scientific field

EXPERIENCE:

• A minimum of 5 years prior experience in Quality Engineering including validation in a pharmaceutical or Life Science position. Equivalent Quality experience can be evaluated.
• Experience in conducting quality investigations and establishing corrective / preventative actions.
• Knowledge of Quality tools such as FMEA, risk analysis methods, validation, sampling plans, Six Sigma and use of statistical methods.
• Applied risk assessment tools and methods to disposition nonconforming product.
• Experience with ISO 13485 standards and FDA cGMP regulations (i.e 21 CFR 820).

KNOWLEDGE, SKILLS, ABILITIES

• Excellent verbal and written communication skills and ability to collaborate across different levels of the organization.
• Excellent organization skills with strong attention to details.
• Ability to multitask efficiently to support production demand.
• Technical proficiency: familiarity with Microsoft Office applications (Word, Excel, and PowerPoint) is required. Proficiency in a statistics data software (Minitab, JMP…etc).
• Lean Sigma Green or Black Belt or ASQ CQE a plus.
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• Use (RCA) methods and tools to investigate process/product deviations and out of specification conditions.
• Implement effective corrective and preventative actions (CAPAs) to eliminate recurrence of deviations and nonconformances.
• Disposition non-conforming material (final product and raw material).
• Write technical reports such investigation summary reports.
• Perform statistical analysis to improve process and product performance.
• Lead and generate risk assessments (product and process- FMEAs).
• Perform process, product and equipment validations (i.e IQ/OQ/PQ..etc) in alignment with GMP requirements including protocol and report generation, acceptance criteria and statistical sampling plans. Conduct validation failure investigations.
• Drive continuous improvements in all areas and support improvements efforts.
• Perform Quality Assurance (QA) responsibilities to support manufacturing activities including support to site’s QMS.