JOB SUMMARY:

We have an immediate opening for a Quality Engineer at our Lithia Springs, GA supporting our Incontinence Care Division. The Quality Engineer is under broad supervision, responsible for independently setting basic quality standards for in-process inspections & testing, while leading efforts to develop methods for testing, sampling and training. Will work closely on the production floor (50-75%) with the manufacturing teams evaluating production process, recommending improvements, assisting with qualifying and conducting vendor management functions. Will also support the needs of corporate DMR requirements, and product specifications.

MAJOR RESPONSIBILITIES:

• Manage the development and implementation of methods and procedures for process control, process validation, process improvement, testing, and inspection to ensure that products are ideal and functional, including leading teams to drive the process/ product improvement project.
• Lead investigations of root cause analyses on product and process non-conformance and out-of-specification results and develop effective corrective and preventive actions (CAPA)
• Design experiments to understand sources of variation affecting products and processes. Applies statistical process control (SPC) methods for analyzing data to evaluate the current process and process changes.
• Provide Quality expertise in Product Development and Risk Management activities.
• Design and perform experimental product testing and analysis to maintain quality levels and minimize defects and failure rates.
• Generate and analyze reports and defective products to determine trends and lead corrective actions. Use concepts of probability and statistical quality control to guide decisions.
• Coordinate product testing with internal and external laboratories as required for root cause analysis and/or experiments testing
• Collaborate with supplier representatives on quality problems, ensuring corrective action implementation (CAPA, SCAR), and contribute to supplier quality improvement programs. Participate in Supplier qualifications process.
• Provide training to Operations and/or quality assurance personnel for new/update documents (SOP's, work instructions,etc.) new and/or existing product specifications and requirements.
• Perform quarterly defect training to team members.

Education

• Typically requires a Bachelor’s degree in Engineering, Science, Math or other related technical field.

Work Experience

• At least 2 years of experience in the Quality or Engineering.

Knowledge / Skills / Abilities

• Experience developing ways of accomplishing goals with little or no supervision, depending on oneself to complete objectives, and determining when escalation of issues is necessary.
• Experience using time management skills to prioritize, organize, and track details in order to meet deadlines of multiple projects.
• Experience problem solving, overcoming obstacles, and reaching a positive and successful solution through mathematical or systematic operations.
• Experience using MS Office Suite products (Word, Excel, PowerPoint, Outlook ).
• Intermediate Skill Level in Microsoft Excel (for example: conditional formatting, tables, formulas, charting)
• Working knowledge of government and industry quality assurance codes and standards (e.g. 21 CFR 820, ISO13485).

PREFERRED JOB REQUIREMENTS

• At least 2 years of industry experience in Medical Devices, Drugs, and/or fields directly related to the role.