Quality System Specialist I

Introduction

Werfen

 

Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain.  We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong.

 

Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We’re passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care.

Overview

Job Summary:

 

Responsible for assisting in the planning, coordination, control, and continuous improvement of key components of the Quality Management System (QMS), while ensuring compliance to GMP requirements, FDA & ISO standards, and other regulations as they pertain to the QMS.  The focus of the position is to assist in maintaining and monitoring key Quality Systems.  Duties may include CAPA, Internal Audits, Supplier Audits, Affiliate Audits, External Documents, Management Review, Procedure development, key metric reporting and other key project support under the supervision of the Quality Systems Manager.

Responsibilities

Key Accountabilities

 

Essential Functions:

The QS Specialist I will be expected to support all activities within the Quality Systems team shown below but will have primary responsibility for assisting and supporting at least one of the following:

• CAPA process – Assist with tracking, trending of approved CAPAs, and driving timely/appropriate completion of activities, ensuring root cause analysis, actions, verification of effectiveness are appropriate
• Internal Audit program – Assist with planning, conducting, reporting, and transfer of any nonconformities issued to the CAPA process and driving timely/appropriate closure of the audit.
• Quality Agreements – Assist with maintaining up-to-date files, updating agreements to current template, communicating with affiliates and/or distributors regarding status under minimal supervision
• Quality Plans – Assist with issuing number, creating plan, tracking status, timely/appropriate closure
• External Documents – Assist with tracking, trending of the External Document process. Driving timely/appropriate initiation and completion of Action Plans.
• Management Review – Assist with the creation and delivery of the Management Review presentation. Assist with completion and approval of the Management Review Meeting Minutes and closure of Action Items.

Secondary Functions:

• Attend meetings related to QS activities
• Assist with change orders/process improvements with respect to Quality Management System procedures with direction from management
• Assist with development and maintenance of a variety of metrics pertaining to Quality System activities as assigned, including data for Management Review and KPIs
• Assists and supports internal, external (including regulatory) and/or 3rd party audits, as needed
• Assists and supports duties in compliance with established business policies
• Other duties as assigned, according to the changing needs of the business

Networking/Key Relationships:

To be determined based on department needs, to include interactions such as:

• All Werfen Departments
• Werfen Affiliate QARA
• Werfen Corporate and other Werfen Manufacturer QARA

Qualifications

Minimum Knowledge & Experience Required for the Position:

 

Education:

• Minimum of bachelor’s degree, in related scientific or technical field

Experience:

• Minimum 1 years (or 1 years with advanced degree) of experience in the medical device, IVD or other regulated industry

Additional Skills/Knowledge:

• Previous Quality Assurance experience within a GMP regulated environment is a plus
• Good understanding of US FDA Quality System Regulations (QSR), ISO 13485:2016, Good Manufacturing Practices & Good Documentation is a plus
• Good computer skills required; expert knowledge of Microsoft Office (including Word, PowerPoint and Excel) required, experience with Enterprise Resource Planning