Quality Systems Specialist

Job Description

We are looking for a skilled Quality System Specialist to join our team at the Branchburg site. This position offers a unique opportunity to lead and develop a data-driven culture within our quality organization and site, reporting directly to the Executive Director, Quality.

As the Quality System Specialist, you will be responsible for analyzing and resolving problems, providing insights, and identifying areas for improvement. Your expertise in quality systems and data will play a crucial role in driving the success of our site. Additionally, you will contribute to resource planning and policy development.

In this role, you will be key in authoring, co-authoring, reviewing, and approving data reports and presentations for various stakeholders, including quality managers, senior management, internal technical groups, and regulatory agencies. Your recommendations for corrective actions will be essential in ensuring compliance and continuous improvement. You will also be responsible for developing efficient data reporting systems that transform raw data into actionable information.

The impact of this position is significant, as your work will ensure overall compliance with regulations for metrics reporting and drive a metrics system that promotes ethical decision-making. Your contribution will also ensure the delivery of safe and compliant products to our customers and patients. Furthermore, you will be pivotal in fostering a culture of accountability and data-driven decision-making within the quality organization and at our Branchburg site.

If you are passionate about quality systems, possess strong data expertise, and thrive in a dynamic environment, we invite you to apply for this position and be part of our team dedicated to delivering excellence in quality and compliance.

Responsibilities:

1. Manage key metrics for the Branchburg Quality organization, including Quality Index, Site Business Review, Quality Systems Management Review, and Post Market Surveillance Review.

2. Provide in-depth insights for each metric, understand the context and drivers for any misses, and represent Branchburg in above-site reviews when required. Own and maintain procedures for Post Market Surveillance, Quality Management System Review, and other assigned procedures.

3. Understand the various systems that house quality data and records, and extract data as needed depending on the information required.

4. Lead the establishment of a metrics-driven culture across the organization, collaborating with key stakeholders to understand data sources, limitations, and opportunities for leveraging data.

5. Develop standard work, enhance knowledge and skills, and integrate metrics into tier structures to drive actions and share best practices.

6. Generate ad hoc reports, develop analytics tools, and use visualization/BI tools to create automated dashboards.

7. Collaborate cross functionally to drive corrective actions to improve metrics. Ensure key metrics are integrated into Tier and monthly review processes.

8. Collaborate cross-functionally on complaint trend monitoring, evaluation, and investigation of signals and potential trends. Generate and maintain Post-Market Surveillance Plans and Periodic Safety Update Reports according to required timelines for medical devices.

9. Monitor and implement processes to ensure compliance with regulations and guidelines, including FDA 21CFR 1271 and 820, ISO 9001 and 13485, EU MDR, Health Canada regulations, AATB, and state regulations.