Process Quality Engineer

Contract Process Quality Engineer Posted on 21 April 26 by Stephanie Krydick Murrysville, PA $40 - $45 per Hour Job Description

Title:

Process Quality Manager

Location:

Murrysville, PA 15668 Job Responsibilities Leads analysis of defects for determining dispositions of non-conformances and drives management of Non-Conformances (NC) and Quality Notifications (QN). Manages the CAPA process, overseeing investigations into nonconformances, determining root causes, and implementing effective corrective and preventive actions, while monitoring CAPA effectiveness. Ensures regular assessment of impact to Process Failure Mode and Effects Analysis (PFMEA) and associated controls in relation to design changes and assists in Manufacturing Process Development and Design Transfer activities. Supports Supplier Quality with investigations and may assist with Supplier Communications, as required and drives support to acceptance activities set up transfer to manufacturing resolve process deficiencies. Supervises non conformance events and investigations in the factory and oversees material review board activities for non-conformance disposition management. Manages operations performance monitoring, reporting, improvement and development, facilitates improvement programs in factory, and supports analytical testing and Supplier Quality Engineering (SQE), Supplier Quality Assurance (SQA) and Purchasing. Possesses working knowledge of generic products/services and Quality Engineering and Continuous Improvement techniques, addresses problems of diverse scope, requiring the evaluation of identifiable factors, demonstrating sound judgment in selecting methods for obtaining solutions, and frequently interacts with supervisors and functional peer groups to gain cooperation of others. Leads timely quality engineering and quality assurance tasks, ensures manufacturing quality systems are maintained, leads single or complex validation and process improvement activities, and helps in completion of New Product Introduction (NPI) and product transfers in factory. Executes process validation protocols, facilitates production builds to support validation activities, analyzes data for reports, process improvement initiatives, and validation activities. Drives strategic initiatives to improve supplier quality, collaborating with cross-functional teams in research and development (R D), manufacturing, and regulatory affairs to address process deficiencies and ensure risk management. Mentors and develops a team of quality engineers, fostering a culture of continuous learning and knowledge sharing, ensuring the successful completion of new product introduction (NPI) projects and smooth product transfers within the factory. Manages talent across the team, while driving employee selection, performance management, compensation management, career development, and ensuring effective operational management. Requirements Minimum required

Education:

Bachelor's / Master's Degree in Mechanical Engineering, Electronics Engineering, Science or equivalent. Minimum required

Experience:

Minimum 2 years of experience with Bachelor's OR Minimum 1 years of experience with Master's in areas such as Quality Engineering, Safety Engineering, Process Engineering or equivalent. Must have supervisory experience Preferred Skills Process Quality Management Data Analysis & Interpretation Design for Quality (DFQ) Root Cause Analysis (RCA) CAPA Methodologies Regulatory Requirements Manufacturing Processes Process Monitoring Privacy, Safety and Security Risk Assessment Technical Documentation Process Engineering Continuous Improvement Product Lifecycle Management (PLM) People Management Experience supervising high-volume, detail-driven execution teams Comfort with daily throughput targets, queue management, dashboards Quality system fundamentals (NC/CAPA/QN vocabulary) and ability to operate in regulated environments Working knowledge of SAP and strong Excel usage Rate / Salary $40 - $45 per Hour Sector Medical Devices Category Quality Engineering Skills / Experience CAPA, RCA, DFQ, Process Quality Management Benefits Full Our Reference

JOB-18783

Rate / Salary $40 - $45 per Hour