Quality Engineer I
- Manage the customer complaint system with the goals of prevention of future occurrences and complaint avoidance utilizing the Root Cause and Correct Action (RCCA) process.
- As part of CAPA implementation: plan, execute, and oversee inspection and testing of products to verify conformance with specifications and deliverables to ensure that all product shipped meets customer requirements in accordance with Customer Specifications.
- Manage substandard/nonconforming materials to the established Site standard operating procedures to ensure that they are controlled within the manufacturing processes and dispositioned appropriately.
- Create, promote and execute quality standards, inspection processes, test methodology, quality plans, documents, reports, etc. to verify conformance with specifications and deliverables.
- Review Material specifications to ensure the necessary criteria and provisions are included to meet the quality and continuous improvement requirements.
- Participate in internal and external quality audits.
- Interface with supplier and customer quality representatives concerning problems with quality assurance of specific items and ensure that effective corrective actions are implemented as necessary while maintaining strong positive working relationships with customers and suppliers.
- Drive continuous improvement activities and stays current with the industry best practices.
- Work directly with machine operators to identify needs and develop solutions; work with Maintenance on equipment modifications and preventative /predictive maintenance to ensure reliability.
- Assess and make improvement recommendations through the monitoring of equipment performance.
- Identify, propose and execute projects to improve customer satisfaction, through performance and product reliability. Develop / improve product reliability, performance consistency and cost effectiveness to support the company’s continuous improvement processes.
- Statistically evaluate process parameters and assess impacts of material changes to efficiency and process integrity, which will result in scrap rate reductions and increase yields.
- Evaluate and update risk assessment tools, such as FMEA/control plans, based on current performance and customer complaint feedback.
- As part of CAPA implementation or Verification of Effectiveness: compile, write and/or review validation and verification protocol activities with accuracy.
- Report to management on quality issues, trends and recommendations through accurate reports as necessary.
- Maintain and protect proprietary information as related to Company and its customers.
- Perform other duties as assigned.
- Attend training programs to develop and maintain relevant knowledge techniques and skills.
- Must be able to support manufacturing operations active 24/7.
- Occasional travel to customers/suppliers may be required.
- Bachelor’s degree in Engineering or related field along with minimum 3 years’ experience.
- Must have strong computer skills to work with Quality Assurance applications, word processing, spreadsheets and databases, etc.
- Demonstrated experience in statistical analysis, Six Sigma, Lean Manufacturing, or formal continuous improvement programs.
- Preferred experience with GMP regulations and ISO 9001 Audits.
- Preferred experience with web manufacturing processes.
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