Quality Analyst I

Werfen•San Diego, CA

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.

Requirements

Bachelors degree (Life Sciences) preferred.
Minimum of Three (3) years related relevant experience required.
Previous Quality Assurance experience within a GMP regulated environment desired.
Prior exposure/experience in records management for a medical device/diagnostics or pharmaceutical company preferred. Computer literacy required; knowledge of Microsoft Office (including Word and Excel) required, experience with Enterprise Resource Planning (ERP) system preferred.
Ability to pay close attention to detail is required.
Strong planning, organizational and time management skills are required.
Must be self-motivated and have the ability to work with minimal supervision; must also be able to work as part of a team. Technical writing background/experience is a plus.
Excellent written and verbal communication skills are essential.

Responsibilities

Manages the on-going maintenance of the Nonconformance process, including tracking, trending, appropriate closure, and effectiveness checks.
Chairs meetings of the Material Review Board (MRB) to review Nonconformance's and monitor trends.
Develops and maintains a variety of metrics pertaining to quality system activities as assigned.
Participates in the development of slides/data for Management Review.
Provides support to the Change Management program and Document Control activities, including but not limited to verification of changes, filing of approved documents, and other duties as assigned.
Conduct internal, external (supplier) and/or 3rd party audits.
Provides assistance in other quality system areas as requested.
Provides support through a general working knowledge of all Accriva quality system programs.
Provides assistance and recommendations based on a clear understanding and implementation of regulatory standards.
As needed, participate in regulatory audits.
Interface with all functions and levels of management as needed.
Work on assigned special projects as needed.