The Sr. Quality Engineer is responsible to perform quality engineering duties including, manufacturing support, quality monitoring, problem solving, process improvement, CAPA management and internal/external auditing. Knowledge of commonly used concepts practices and procedures within the field are required. The position relies on training, experience and judgment to plan and accomplish goals. A certain degree of creativity and latitude is required while performing a variety of complex tasks.
- Drive the identification, implementation, and use of statistical methods throughout the plant. Statistical methods include Statistical Process Control (SPC), Designed Experimentation (DoE), and acceptance sampling among others.
- Establish, monitor, analyze, and report on the major quality indicators for the plant. Utilize accepted capability indicators (CP, CpK, PPM, etc.).
- Create and facilitate problem-solving teams; including the use of problem solving tools such as FMEA.
- Investigate, analyze, develop and determine processes and process improvements on existing products to improve quality and or productivity.
- Develop and implement quality tools in the line such as defect tracking, random audits, verification check sheets, etc.
- Assist establishing, implementing, and maintaining the quality management system.
- Responsible for continual improvement activities to enhance the quality system, such as 5S, Kaizen lean methods, etc.
- Plan and implement projects to improve quality control and monitor internal quality.
- Conduct audits, including closing out audit findings, creating audits finding reports and determine proper corrective and preventive actions.
- Analyze failure, corrective and preventive action to respond to customer complaints.
- Interface with external customers and suppliers on quality-related issues.
- Create and maintain company quality documentation, such as quality manuals, quality procedures, etc.
- Continuously improving QA receiving inspection process and procedures.
- Ensure timely resolution of supplier failure, corrective actions and preventive actions.
- Manage suppliers’ performance and conduct audits.
- Perform duties in accordance with established quality standards.
- Actively support Health, Safety and Environment rules and regulations.
- All other duties and responsibilities as assigned
- BS in Manufacturing or Industrial Engineering.
- Min 5+ years of experience in manufacturing quality environment.
- Working knowledge of ISO 9001:2015.
- ASQ Certified Quality Engineer or Certified Quality Auditor preferred.
- Six sigma green / black belt certified and Lean Manufacturing experience.
- Experience in a cGMP and FDA regulated environment preferred.
- Quality systems auditing experience; preferably as a lead auditor.
- Experience in MRB, design reviews, supplier audits, corrective action programs.
- Thorough understanding of QA standards, implementation and auditing.
- Thorough understanding of statistical techniques and analyses.
- Strong knowledge and use of MS Office applications, integrated MRP database applications, and experience with Minitab also desired.
- Excellent verbal and written communication skills.
- Experience in driving improvement initiatives.
- Ability to integrate and work well in a team environment.
- Effectively manage multiple and changing priorities.
- Ability to work in a fast-paced environment.
- Ability to lift 50 lbs. on occasion.
- Occasional travel required.