Quality Engineer

Summary

The Staff Engineer, Quality is responsible for providing product quality and engineering support focused on product compliance in support of Product Design and Manufacturing, including the critical quality system elements, Complaint Investigations, Risk Management (pFMEA), Process/Test Method/Equipment Validations, Deviations, Control of Nonconforming Product, Product Holds, and Equipment management support to the Operations and Quality departments. Responsible for equipment and process improvement projects, supporting introduction of new processes or equipment into the facility.

Leading investigational activities around non-conformances and CAPA’s. Works collaboratively with Operations, Manufacturing Engineering, Design Engineering and Post-Market Surveillance groups to ensure a high level of product quality and effective and efficient investigations when needed. Consults with management to resolve quality, production, and efficiency problems. Functions in conjunction with manager and functional experts on special department projects. Works with internal departments to ensure implementation, maintenance, and improvement of the quality management system.

Seasoned professional with complete and in-depth conceptual and practical knowledge in providing quality and engineering support decisions in a manufacturing environment. A self-starter that requires minimum supervision in the execution of primary responsibilities. Utilizes complete and in-depth conceptual and practical knowledge in own job discipline and basic knowledge of related job disciplines. Applies knowledge of job discipline's best practices to internal processes.

Positions at this level are individual contributors that are also capable of leading cross-functional teams. Writing & coordinating efforts for the development and implementation of new and updated Quality System procedures for ISO/QSR, such as validation protocols, manufacturing procedures, product & material specifications, design & development documentation, SOPs, development, and task force projects. Leads multi-disciplined team in the development and execution of Process FMEA and other applicable risk analysis as deemed appropriate.

Oversees and participates in risk management processes, including the identification, evaluation, and mitigation of potential risks associated with product quality, safety, and regulatory compliance. Develop, collect, analyze, and report quality metrics. Develop statistically based sampling plans for in-process and final testing and inspections, and validations. Work with project teams to develop DOEs and statistically sound tests for appropriate support of results.

Develop, review and approve validations and completion reports for new and existing products, processes and equipment. Provide statistical analysis of the data to support the reports. Ensure that all projects are compliant with GLP, QSR (including Design Controls), ISO or other applicable requirements. Formulate detailed product quality plans based on results of risk analysis. Support as required the quality management review process.

Participate in FDA inspections, ISO certification and surveillance audits and customer audits. Support corporate regulatory affairs by providing information for submissions and annual reports. Identify and implement opportunities for continuous improvement. Audit internal groups or programs and external vendors for compliance with corporate and international regulatory guidelines. Interact and coordinate activities with other departments, external vendors and customers. Work with Product Development team in order to ensure all aspects of Design Transfer activities are being met.

As required, assist or lead in the prompt implementation of non-conformance resolution. Identifying and investigating quality issues, conducting root cause analysis, and implementing corrective and preventive actions (CAPAs) to address non-conformities and improve product quality. Aid in the implementation SPC (Statistical Process Control) control systems with Manufacturing and Quality Control as applicable. Able to support manufacturing by…