Process Quality Manager-Onsite

Elyon International•Murrysville, PA

12d•Onsite

About The Position

The Process Quality Manager will lead analysis of defects, manage Non-Conformances (NC) and Quality Notifications (QN), and oversee the CAPA process. This role ensures regular assessment of impact to PFMEA and associated controls, supports Supplier Quality, and manages operations performance monitoring and improvement programs. The manager will also lead quality engineering and assurance tasks, execute process validation protocols, drive strategic initiatives to improve supplier quality, and mentor a team of quality engineers. Key responsibilities include talent management, employee selection, performance management, compensation management, and career development.

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.
Supervisory experience is required.

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
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

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.