Quality Engineer

SUMMARY You will be responsible for supporting production by identifying opportunities and leading the investigation and solutions for quality-related supplier, production, manufacturing, and design-related issues. RESPONSIBILITIES Provide engineering support to operations ensuring consistent application of quality techniques Support the Quality Inspectors to ensure that products and processes comply with the relevant requirements of the quality management system Conduct audits, including closing out audit findings, creating audits finding reports and determine proper corrective and preventive actions Effectively communicate and reinforce commitment to quality improvement efforts Determine when process stability and capability studies should be performed on existing processes. Review and analyze results. Recommend changes to processes based upon findings and perform follow up to verify effectiveness Participate in the planning activities to determine appropriate use of existing and new measurement systems during new tool or process design and startup Facilitate and promote the use of appropriate problem-solving techniques for effective root cause analysis and successful corrective action Knowledge & application of Statistical Process Control (SPC) techniques/principles Determine and apply appropriate Measurement System Analysis tools Systems Management: Recommend and implement enhancements to the quality system that result in improved corporate quality performance, increased customer satisfaction, and/or simplification of processes to reduce costs Assist in ensuring readiness for all internal and external quality audits Participate in the development of the annual audit plan, train internal audit team members, perform necessary duties as Lead Internal Auditor and provide ongoing communication/reporting of results Participate in quality reporting and management review process Review equipment validations to support ad-hoc limited qualifications, new equipment qualifications, equipment and facility requiring re-qualifications, calibrations, etc. Ensure appropriate qualifications activities are performed and documented in compliance with GMPs, GTPs, and GDPs. Review and approve validation documents in an electronic equipment maintenance documentation system. Support the Risk Management process throughout all quality system elements such as Design Control, Product Surveillance, Field Action, etc. Update risk management file documents as needed. Provide Quality support for product quality manufacturing issues ensuring compliance with applicable regulations/standards as well as providing sound technical guidance Provide guidance and direction on Client and CAPA investigations. Complete NCRs and CAPAs, as required including risk assessments Assist Quality manager in establishing, implementing, and maintaining the quality management system REQUIRED SKILLS Bachelor's degree in Engineering or a related field Minimum of 3+ years experience in quality control in a manufacturing environment Strong analytical and problem-solving skills Knowledge of project management principles and methodologies Excellent communication and interpersonal skills Detail-oriented with a focus on accuracy and precision Proficient in using the seven quality management tools and software RECOMMENDED SKILLS 5+ years experience in quality control in a manufacturing environment Experience in implementing, managing, and maintaining QMS Certification of quality control is a strong advantage (ISO 13485 / ISO 9001, etc.) Thorough knowledge of quality control standards and testing methodologies Certified Quality Engineer Training or Certification Six Sigma Green or Black Belt Training or Certificaiton WORK ENVIRONMENT Production Office working environment. Frequently exposed to moving mechanical parts and an increased noise level.