Quality Engineer

Job Summary

Plan, schedule, execute & communicate all items regarding quality issues, complaints, validations & other projects to QA Manager and/or other interested parties. Provide technical assistance for developing and maintaining measurement routines for the various vision measuring system. Provide quality assistance in support of new product development and validation. Support customer complaint process. Provide quality assistance including SPC support with facility manufacturing, engineering, maintenance, shipping and warehouse functions. Be a quality resource in the improvement of all aspects of plant operations and in the plant’s relations with its customers and suppliers. Perform all duties associated with the auditing and documentation of compliance related items against ISO standards.

Essential Duties and Responsibilities

- Provides technical and quality support by: - Assisting facility and design development personnel as needed for engineering/projects. - Providing guidance and training to all QA personnel about new operation and programming of vision system equipment. - Providing backup support to QA Manager and/or QA Supervisor, as needed. - Assisting in the investigation of customer complaints to ensure timely response. - Assisting in maintenance and improvement of facility required quality systems including ISO 13485 and HACCP. - As required, work with Manufacturing, Engineering, Sales, the Customers and Suppliers to resolve issues on new products. (This may require travel.) - Become knowledgeable in all areas of the Q.A. Department and work with the various functions within Q.A. to resolve internal issues as they arise. - Perform audits of the various departments / functions as directed by the Q. A. Manager. - As required, participate and or lead Customer meetings / audits, Supplier meetings / audits and corporate audits. - Work with management and technical staff in performing root cause failure analysis and implementing corrective and preventative actions to preclude recurrence (CAPA). - Ability to closely interact with customers to understand and integrate those requirements into West manufacturing and quality system requirements - Work independently and with project teams to develop design control deliverables including quality plans, manufacturing and inspection documentation, test methods, and any necessary records for filing tooling product history files - Complete dimensional analysis for OQ & PQ as needed to include capability, normality and transformation of data when required. - Create validation protocols (IQ, OQ & PQ) and obtain customer approval, when applicable. - Complete validation reports and submit to internal and external teams as applicable. - Aid in validating and reviewing validations of equipment, products and processes. - Develop and execute Gauge R&R studies to ensure confidence in defined measuring techniques. When applicable, work with QA Supervisor to develop/execute plan for improvements (equipment, training, etc.). - Assist Measuring Techs in the evaluation of and possible improvements to defined measurement routines, fixtures and troubleshooting of problems related to the vision measuring system. - As directed by the QA Manager, represent the facility QA, engineering, and manufacturing groups for new products. As a member, ensure plant S.O.I.’s and Corporate G.O.P.’s are being followed and ensure all necessary testing and evaluations have been completed prior to completion and final approval. - Drive site and departmental goals/KPI’s in the improvement of Cost of Poor Quality and Yield Opportunity to 100%

Education

- Bachelor’s degree preferably in technical discipline; Science, Engineering, Quality Assurance, or a related field.

Work Experience

- Background in SPC, Root Cause and Corrective Action (Exposure to 8D or A3 methodology preferred). - Experience: 3+ Years as a quality or engineering professional in a manufacturing environment.