Title: Quality Management System Manager
Location: Quakertown (On-site)
Schedule: M-F 8 am-5 pm
Type: Direct/Permanent
Target Salary Range: $145,000 to $160,000 + 15% bonus
Start date: Immediate

Are you ready to take the next step in your quality management career? We are looking for a passionate and results-driven Quality Management Systems Manager to lead our CAPA processes, manage audits, and collaborate with regulatory bodies to ensure our products meet the highest standards. In this pivotal role, you’ll have the opportunity to own and enhance our QMS while driving continuous improvement across the organization. If you thrive in a fast-paced, medical device environment and excel in solving complex challenges, we want to hear from you!

Responsibilities: Lead CAPA processes, including root cause analysis, corrective/preventive actions, and timely resolution of quality issues. Hosting audits including but not limited to supplier, internal, and external audits, ensuring compliance with FDA, ISO 13485, and MDR standards. Notify regulatory bodies of significant changes and maintain readiness for audits and inspections. Oversee the implementation and maintenance of the Quality Management System (QMS) to ensure alignment with regulatory requirements specific to medical devices. Collaborate with cross-functional teams to address quality issues and enhance product compliance. Manage document control systems, including the creation, revision, and approval of SOPs and quality records. Conduct risk assessments and implement risk mitigation strategies as part of the quality planning process. Ensure proper training and competency for employees on quality policies, procedures, and best practices. Identify opportunities for process improvements and lead quality-related training programs to enhance organizational competence. Prepare and maintain accurate records, reports, and updated SOPs related to CAPA and audits.
Requirements: Bachelor’s Degree required. Minimum of 10 years of experience within the medical device, pharmaceutical, or medical manufacturing industries. In-depth knowledge of CAPA processes, internal and external audits, and regulatory requirements (e.g., FDA, ISO 13485). Strong problem-solving skills with experience in root cause analysis and risk management. Familiarity with quality management software is required; experience with TrackWise is preferred but not essential.

System One, and its subsidiaries including Joulé, ALTA IT Services, TeamPeople, and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.