Process Quality Manager-Onsite

Elyon International•Murrysville, PA

2d•Onsite

About The Position

The Process Quality Manager leads the analysis of defects to determine dispositions for non-conformances and manages Non-Conformances (NC) and Quality Notifications (QN). This role is responsible for overseeing the CAPA process, including investigations, root cause analysis, and implementation of corrective and preventive actions, while monitoring their effectiveness. The manager ensures regular assessment of Process Failure Mode and Effects Analysis (PFMEA) impacts related to design changes and supports manufacturing process development and design transfer activities. Key responsibilities also include supporting Supplier Quality investigations, supervising non-conformance events in the factory, and managing material review board activities. The position involves monitoring and improving operations performance, facilitating improvement programs, and supporting analytical testing. The manager is expected to possess working knowledge of Quality Engineering and Continuous Improvement techniques, address diverse problems, and interact with supervisors and peer groups. This role leads quality engineering and assurance tasks, maintains manufacturing quality systems, drives validation and process improvement, and assists with New Product Introduction (NPI) and product transfers. Furthermore, the manager executes process validation protocols, analyzes data for reports, drives strategic initiatives to improve supplier quality, and collaborates with cross-functional teams. A significant aspect of the role is mentoring and developing a team of quality engineers, fostering continuous learning, and managing talent through selection, performance management, compensation, and career development.

Requirements

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

Nice To Haves

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

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.