Position Title: Quality Engineer
SUMMARY: Develop and implement quality systems with an emphasis on proactive measures to drive the new product development milestone process and CAPA in an effort to enhance preventive action and responsiveness to internal and customer complaints relevant to manufacturing processes. Technical knowledge and aptitude to analyze, report, promote process improvement, develop standards, manufacturing methods and procedures supporting innovation, corrective actions, and overall customer insights.
ESSENTIAL DUTIES AND RESPONSIBILITIES: include the following. Other duties may be assigned.
- Responsible for Quality Management System inclusive of process and procedure development/implementation that aligns with ISO standards
- Determines quality improvement parameters by identifying statistical methods relevant to manufacturing processes.
- Enhance quality inspection process utilizing statistical confidence by identifying sample size and acceptable error; determining levels of confidence
- Analyzes data by completing hypothesis, normal distribution, and process capability analysis tests
- Develops sampling plans by applying attribute, variable, and sequential sampling
- Root cause analysis and implementation of CAPA for quality improvement related concerns utilizing DMAIC methodology and 8D/5Why tools.
- Assist Quality Director and team in establishing, implementing and maintaining the quality management system with ISO standards methodology
- Responsible for continual improvement activities to enhance the quality system, such as 5S, Kaizen lean methods, etc.
- Develop training to build quality awareness for both QA/QC team members
- Drive new product development milestone process to meet quality, customer, and overall Burkert QMS standards
- Conduct audits, including closing out audit findings, and managing internal QMS audit team
- Analyze failure, corrective and preventive action to respond to customer complaints.
- Create and maintain company quality documentation, such as quality manuals, quality procedures, etc.
- Responsible for planning, organizing and managing the overall activities of receiving / outgoing quality functions.
- 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.
- Preparation of QA reports.
Education & Experience:
- Thorough knowledge of quality systems is required (statistics, reliability, sampling, and auditing).
- 3-5 years preferred in Quality Engineering or Technical Discipline
- Bachelor’s degree in Engineering or Technical Major; Masters Degree a plus
- Manufacturing environment experience
- FDA/RoHS/Conflict Minerals/Product Safety experience a plus
- Knowledge of ISO Quality Management Systems standards
- PPAP, APQP, Control Plans, PFMEA, and SPC
- GD&T/Engineering Prints; AutoCAD a plus
- Six Sigma Green Belt or Black Belt certification a plus
- Lean Implementation in a production, warehousing and distribution environment
- Excellent interpersonal and communications skills, written & verbal
- Proficient with SAP, Microsoft Office (Excel, Word, PowerPoint)
- Strong problem solving skills and ability to multi-task; Proven ability to make sound decisions and recommendations; Perform duties with a high degree of efficiency and accuracy
- Travel 10% - 20%
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