Process Quality Manager

Process Quality Manager#26-06073 Murrysville, PA All On-site Job Description 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 processpliance, 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, ensuringpliance 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,pliance, 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. Regulatorypliance (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. Strongmunication and stakeholder management. Ampcus is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veterans or individuals with disabilities.