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

As an Engineer III in Quality Assurance at Thermo Fisher Scientific, you will play a crucial role in supporting a life science manufacturing facility located in Detroit, MI, specifically within the BioProduction Group (BPG). Your primary responsibility will be to drive quality goals and objectives by providing comprehensive Quality Assurance support. This includes conducting thorough root cause analyses (RCAs) and implementing effective corrective and preventative actions (CAPAs) to ensure compliance with Good Manufacturing Practices (GMP) and safety standards. You will be instrumental in maintaining the integrity of the manufacturing process and ensuring that all products meet the required quality standards. In this position, you will utilize various RCA methods and tools to investigate any process or product deviations, as well as out-of-specification conditions. Your expertise will be essential in implementing CAPAs to eliminate the recurrence of deviations and nonconformances. You will also be responsible for the disposition of non-conforming materials, which includes both final products and raw materials. Writing technical reports, including investigation summary reports, will be a key part of your role, as will performing statistical analyses to enhance process and product performance. Additionally, you will lead and generate risk assessments, particularly focusing on product and process Failure Mode and Effects Analyses (FMEAs). Your responsibilities will also encompass performing validations of processes, products, and equipment in alignment with GMP requirements. This includes generating protocols and reports, establishing acceptance criteria, and developing statistical sampling plans. You will conduct validation failure investigations and drive continuous improvements across all areas of the operation, supporting improvement efforts and ensuring that Quality Assurance responsibilities align with the site's Quality Management System (QMS).

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 QMS.

Requirements

• Bachelor of Science (BS) in a scientific field.
• 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) and familiarity with statistical data software (Minitab, JMP, etc.).

Nice-to-haves

• Lean Sigma Green or Black Belt or ASQ CQE certification.