Quality Systems Manager

Overview

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

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 include managing Document Control and CAPA functions, ensuring robust governance, timely execution, and effectiveness of quality system processes. The role partners cross-functionally with Operations, Engineering, and Supply Chain to embed quality into all stages of the product lifecycle and to support audit readiness and inspection success.

Responsibilities

* Audit Leadership & Regulatory Readiness Lead 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 Own 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.

* CAPA & Complaint Management Oversight 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.

* Process & Product Quality Improvement Conduct process and product audits to identify gaps and drive continuous improvement initiatives using Lean and risk-based methodologies.

* Regulatory & Customer Interface Provide leadership in regulatory matters and serve as a key quality representative to customers, ensuring alignment with regulatory requirements and customer expectations.

* Global QMS Strategy & Standardization Establish and maintain a global QMS framework that supports multi-site operations, harmonization, and future growth, including acquisitions and integration efforts.

* Supplier Quality Integration Represent Quality on the Supplier Qualification Team, co-chair supplier performance reviews, maintain the Approved Supplier List (ASL), and lead supplier audits to ensure supplier compliance and performance.

* Training & Quality Culture Development Develop and sustain QMS training programs to drive compliance, enhance quality awareness, and build a culture of accountability and continuous improvement.

* Cross-Functional Collaboration Partner with Quality, Operations, Engineering, and other functions to implement QMS improvements that enhance efficiency, compliance, and product quality.

* Digital QMS Systems Management 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 to the QMS team, fostering a high-performing organization with strong accountability, engagement, and capability development.

Qualifications

Quality Systems Manager Requirements:

* Bachelor's degree or 6 years of equivalent work experience

* 5 years of experience managing quality management systems

* Experience with ISO 13485:2016 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

Quality Systems Manager Preferred Requirements:

* Quality systems experience in a manufacturing setting

* Continuing education; including participation in local chapters, associations, and/or organizations

What is it like to work at Cretex Medical?

We recognize the contribution of every individual and promote growth, safety and security for all our employees. Cretex Medical values performance and pays competitive wages along with a rich benefit package. We offer a positive work environment with a focus on…