Process Quality Manager

Ampcus Inc. is a certified global provider of a broad range of Technology and Business consulting services. We are in search of a highly motivated candidate to join our talented Team.

Job Title: Process Quality Manager

Location(s): Murrysville, PA

Job Summary:
The Process Quality Manager is responsible for leading manufacturing quality systems, driving non-conformance and CAPA processes, and supervising a team of quality engineers in a regulated, high-volume environment. This role ensures product and process compliance, supports new product introduction (NPI), and leads continuous improvement initiatives across operations and supplier quality.

Key Responsibilities:

• Lead end-to-end management of Non-Conformances (NC) and Quality Notifications (QN), including defect analysis, disposition decisions, and closure.
• Own and drive the CAPA process, including investigation, root cause analysis (RCA), implementation of corrective/preventive actions, and effectiveness monitoring.
• Supervise Material Review Board (MRB) activities and ensure timely resolution of non-conformance events within manufacturing.
• Assess impact of changes on PFMEA and ensure alignment with process controls and risk mitigation strategies.
• Support Manufacturing Process Development and Design Transfer, ensuring quality readiness for production.
• Partner with Supplier Quality (SQE/SQA) on investigations, supplier performance improvement, and issue resolution.
• Monitor and report on operations quality performance, driving continuous improvement initiatives and process optimization.
• Lead process validation activities, including protocol execution, production builds, and data analysis.
• Support New Product Introduction (NPI) and product transfers, ensuring compliance with quality and regulatory requirements.
• Collaborate cross-functionally with R&D, Manufacturing, Regulatory Affairs, and Purchasing to address quality risks and process deficiencies.
• Develop, mentor, and manage a team of quality engineers, including performance management and career development.
• Drive a culture of quality, compliance, and continuous improvement within the factory.

Required Qualifications:

• Bachelor's or Master's degree in Mechanical Engineering, Electronics Engineering, Life Sciences, or related field.
• 5+ years of experience in Quality Engineering, Process Engineering, or Manufacturing Quality.
• 2+ years of supervisory or team leadership experience.
• Strong experience in regulated environments (e.g., medical devices, pharma, or similar).
• Hands-on experience with CAPA, NC, QN systems.
• Experience with Root Cause Analysis (RCA) methodologies such as 5 Whys and Fishbone.
• Experience with PFMEA and risk management tools.
• Proficiency in SAP and advanced Excel (data analysis, dashboards).
• Experience managing high-volume, metrics-driven operations (throughput, queues, KPIs).

Preferred Skills:

• Design for Quality (DFQ) and Product Lifecycle Management (PLM).
• Statistical analysis and data interpretation.
• Process validation and manufacturing process control.
• Regulatory compliance (FDA, ISO 13485, etc.).
• Strong documentation and technical writing skills.
• Experience in supplier quality management.

Key Competencies:

• People leadership and team development.
• Analytical problem-solving.
• Cross-functional collaboration.
• Operational excellence and continuous improvement.
• Strong communication and stakeholder management.