Engineer III, QA

Thermo Fisher Scientific - Detroit, MI

Full-time - Mid Level

Detroit, MI

10,001+ employees

Computer and Electronic Product Manufacturing

About the position

The Quality Assurance Support role at Thermo Fisher Scientific involves providing essential quality assurance services to a life science manufacturing facility in Detroit, MI. The position focuses on driving quality goals and objectives through root cause analysis, corrective and preventative actions, and validation principles to ensure compliance with Good Manufacturing Practices (GMP).

Responsibilities

• Conduct root cause analysis (RCAs) for 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 including 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) 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 improvement efforts.
• Perform Quality Assurance (QA) responsibilities to support manufacturing activities, including support to the site's Quality Management System (QMS).

Requirements

• Bachelor of Science (BS) in a scientific field.
• A minimum of 5 years prior experience in Quality Engineering including validation in a pharmaceutical or Life Science position.
• 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).
• 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 in Microsoft Office applications (Word, Excel, and PowerPoint).
• Proficiency in statistical data software (Minitab, JMP, etc.).

Nice-to-haves

• Lean Sigma Green or Black Belt or ASQ CQE.