Quality System Specialist I

Werfen•Bedford, MA

6d•$65,000 - $80,000•Onsite

About The Position

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. 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.

Requirements

Minimum of bachelor’s degree, in related scientific or technical field
Minimum 1 years (or 1 years with advanced degree) of experience in the medical device, IVD or other regulated industry
Good computer skills required; expert knowledge of Microsoft Office (including Word, PowerPoint and Excel) required
Basic understanding of change control requirements
Basic understanding of record retention
Good ability to pay close attention to detail is required
Work is accurate and completeness of records
Demonstrated good ability to meet department goals
Integrity and Trust / Ability to be Discrete
Good ability to Learn on the Fly / Taking Initiative
Good written and verbal communication skills
Acts Honest, Loyal, Trustworthy
Good planning, organizational and time management skills are required to support changing business needs
Good ability to work with cross functional teams
Must be self-motivated and have the ability to work under minimal supervision; must also be able to work as part of a team
Must demonstrate professionalism during all interactions within company, customer and third parties
Good ability to drive continuous improvement, correct deficiencies and to prevent recurrence
Good problem-solving skills are required

Nice To Haves

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
experience with Enterprise Resource Planning (ERP) system (such as SAP) is a plus

Responsibilities

Assist with tracking, trending of approved CAPAs, and driving timely/appropriate completion of activities, ensuring root cause analysis, actions, verification of effectiveness are appropriate
Assist with planning, conducting, reporting, and transfer of any nonconformities issued to the CAPA process and driving timely/appropriate closure of the audit.
Assist with maintaining up-to-date files, updating agreements to current template, communicating with affiliates and/or distributors regarding status under minimal supervision
Assist with issuing number, creating plan, tracking status, timely/appropriate closure
Assist with tracking, trending of the External Document process. Driving timely/appropriate initiation and completion of Action Plans.
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.
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