Senior Quality Engineer (GP) in Hayward, California at Delphon Industries, LLC dba Gel-Pak

The Senior Quality Engineer provides advanced quality-engineering leadership for the Hayward facility and supports the Quality Management System in alignment with applicable standards, customer requirements, and regulatory expectations. The position partners with leadership and cross-functional teams to improve product quality, manage risk, support audits, and strengthen quality systems for Gel-Pak and TouchMark operations.

Responsibilities may change based on business needs. Employees must be able to perform the essential functions of the position, with or without reasonable accommodation. Key responsibilities include:

· Develop and support long-term quality strategies for product design, development, and production.

· Lead complex investigations of product and process nonconformances and oversee corrective and preventive actions and documentation.

· Lead resolution of significant customer complaints, return merchandise authorizations, and supplier corrective action requests.

· Support governance and improvement of International Organization for Standardization (ISO) 9001 quality management systems and lead customer, corporate, and regulatory audits as assigned.

· Review quality records and significant manufacturing deviations in accordance with document-control and approval requirements.

· Lead Material Review Board activities, Failure Mode and Effects Analysis, failure analysis, and risk-mitigation activities.

· Develop and optimize control plans, inspection standards, and calibration systems.

· Define and report key performance indicators, efficiency measures, and quality metrics and apply the Define, Measure, Analyze, Improve, and Control methodology.

· Partner with Engineering, Production, and Customer Service to reduce process variation and address quality issues.

· Provide technical oversight for change control, coordinate-measuring-machine programming, process capability analysis, and Gage Repeatability and Reproducibility studies.

· Lead or support management reviews, customer surveys, and installation, operational, and performance qualification activities.

· Improve use of enterprise quality management, enterprise resource planning, statistical analysis, and quality-dashboard systems.

· Analyze Cost of Poor Quality and quality-related gross-margin impacts and recommend improvement actions.

· Perform other duties as assigned over the course of employment.