Quality Management

• Internal and External Audits

• Quality Control & Quality Assurance

• Receiving Inspection and Materials

• Participate in QA process, developed include Flow Charts and Control Plans.

• Develop the required documentation for each specific customer requirements.

• Maintain customer contacts by being proactive and reactive to all customer concerns for internal and external customers.

• Perform capability studies as required.

• Participated in internal auditing and layered audits.

• Developed, implemented, and provided training.

• Participate on multiple Project Teams as a Quality Engineering Representative, ensuring compliance to regulatory standards and providing input into   the project design input requirements and product development quality plans.

• Proficient in application of Design Controls, Good Manufacturing Practices and ISO.

• Developed and validated various test methods.

• Established In-process Production and Final QA Inspections plans.

• Provided technical guidance to Quality Technicians and Inspectors.

• Utilized statistical methods, such as, process capability data analysis, statistical process control (SPC), and scientific sample size selection to ensure   processes capability and repeatability and to determine statistically valid sampling plans.

• Provided technical support to solve quality problems in product development and manufacturing.

• Performed Design of Experiments to support process optimization.

• Participated and conducted the design transfer and design review aspects of design control for QE input / support.

• Conducted Internal Audits per Internal SOP, QSR Regulations, and ISO requirements.

• Analyzes data by completing hypothesis, normal distribution, and process capability analysis tests.

• Prepares reports by collecting, analyzing, and summarizing data; making recommendations.

• Internal – Regularly interact with Materials, Quality, Engineering, Sales, and all Manufacturing functions.

• External – Regularly interact with all levels of customers and prospects.

• Offers exemplary customer service, including maintaining customer relationships and ensuring repeat customers by up-selling products and services  and taking care of any customer concerns or complaints quickly and professionally.