Quality Systems Manager

About Cretex Medical

Cretex Medical is a leading contract manufacturer of precision components and assemblies for the medical device industry. Our customers view us as a trusted partner in the areas of injection molding, laser processing, metal stamping, and device assembly. Learn more at www.cretexmedical.com.

Quality Systems Manager Position Summary

The Quality Systems Manager is responsible for the development, implementation, maintenance, and continuous improvement of the Quality Management System (QMS) in compliance with applicable regulatory requirements (e.g., FDA 21 CFR Part 820, ISO 13485, and other global standards).

Key Responsibilities

• Manage Document Control and CAPA functions
• Ensure robust governance, timely execution, and effectiveness of quality system processes
• Partner cross-functionally with Operations, Engineering, and Supply Chain to embed quality into all stages of the product lifecycle and support audit readiness and inspection success

Audit Leadership & Regulatory Readiness

• Provide leadership oversight to second- and third-party audits, including preparation, execution, reporting, and closure of audit findings
• Ensure sustained inspection of readiness and successful outcomes with regulatory bodies and customers

Internal Audit Program Management

• Provide leadership oversight the internal audit program, including auditor selection, training, audit scheduling, execution, and driving timely and effective corrective actions to strengthen the QMS

QMS Compliance & Continuous Improvement

• Develop, maintain, and continuously improve a robust Quality Management System compliant with ISO 13485, FDA 21 CFR Part 820, and applicable global regulations, ensuring scalability with organizational growth
• Lead CAPA facilitators and ensure effective management of customer complaints and internal CAPAs, including root cause analysis, corrective/preventive actions, effectiveness checks, and trend analysis
• Conduct process and product audits to identify gaps and drive continuous improvement initiatives using Lean and risk-based methodologies
• Provide leadership in regulatory matters and serve as a key quality representative to customers, ensuring alignment with regulatory requirements and customer expectations
• Establish and maintain a global QMS framework that supports multi-site operations, harmonization, and future growth, including acquisitions and integration efforts
• Represent Quality on the Supplier Qualification Team & supplier performance reviews, ensure that Approved Supplier List (ASL), and supplier audits meet regulatory standards

Process & Product Quality Improvement

• Develop and sustain QMS training programs to drive compliance, enhance quality awareness, and build a culture of accountability and continuous improvement
• Partner with Quality, Operations, Engineering, and other functions to implement QMS improvements that enhance efficiency, compliance, and product quality
• Implement, maintain, and optimize Global QMS software, ensuring system effectiveness, data integrity, and user adoption

Management Review & Metrics

• Support preparation and presentation of Management Review inputs, ensuring clear visibility to QMS performance, risks, and improvement opportunities

Team Leadership & Development

• Lead, coach, and mentor the QMS team, fostering a high-performing organization with strong accountability, engagement, and capability development

Qualifications

• Bachelor’s degree or 6 years of equivalent work experience
• 5 years of experience managing quality management systems
• Experience with ISO 134852016 and FDA Lead Auditor Certification
• Ability to consistently achieve short and long-term business results
• Ability to prioritize work and manage multiple tasks when needed
• Ability to follow through on commitments and hold team members accountable
• Consistently produces work that meets the customer’s requirements
• Project management skills
• Microsoft Office proficiency (Outlook, Word, Excel, PowerPoint, Publisher)
• Clear and effective verbal and written communication skills
• Attention to detail
• Organizational skills
• Ability to work in a fast-paced team environment
• Ability to prioritize and multitask

Preferred Requirements

• Quality systems experience in a manufacturing setting
• Continuing education; including participation in local chapters, associations, and/or organizations