Under the direction of the Sr Quality Manager, TN Site, perform quality engineering duties including, manufacturing support, quality monitoring, problem solving, process improvement, CAPA management and internal/external auditing.
- 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 Sr. Quality Manager in 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.
- 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 on quality-related issues.
- Create and maintain company quality documentation, such as quality manuals, quality procedures, etc.
- Perform duties in accordance with established quality standards.
- Actively support Health, Safety and Environment rules and regulations.
- BS in Manufacturing or Industrial Engineering or other technical field with 2 – 4 years of experience or Associates degree in technical field with 5-7 years of experience
- Experience in MRB, design reviews, corrective action programs.
- Basic understanding of QA standards, implementation and auditing.
- Basic understanding of statistical techniques and analyses.
- 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.
- Ambitious self-starter with drive to implement and achieve desired results.
- Effectively manage multiple and changing priorities.
- Ability to work in a very fast-paced environment.
- Ability to lift 50 lbs. on occasion.
- Occasional travel required.
- Working knowledge of ISO 9001:2015
- Knowledge and experience with ISO 13485
- ASQ Certified Quality Engineer or Certified Quality Auditor.
- 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.