Quality Systems Specialist III

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. Position Summary: The Quality Systems Specialist III is responsible for assisting in the planning, coordination, control, and continuous improvement of key components of the Quality Management System (QMS), which helps to ensure compliance to GMP requirements, FDA & ISO standards, and other regulations as they pertain to the QMS. This is a temporary position to help our team with a major project. The role is planned through the end of 2026, with potential for extension or conversion depending on business needs. The base salary range for this role is currently $90,000 to $110,000. Individual employee compensation will ultimately depend on factors including education, relevant experience, skillset, knowledge, and particular business needs.

Requirements

Bachelor’s degree (Life Sciences) preferred
Minimum of Five (5) years relevant experience or two (2) years relevant experience with an advanced degree required
Previous Quality Assurance experience within a GMP regulated environment required
Strong understanding of Quality Management Systems is required
Strong planning, organizational and time management skills are required
Ability to prioritize urgent matters
Good understanding of US FDA Quality System Regulations (QSR) is required
Good understanding of ISO 13485:2016 is required
Good understanding of Good Manufacturing Practices & Good Documentation Practices
Good understanding of change control requirements
Good understanding of record retention
Computer literacy required; knowledge of Microsoft Office (including Word, PowerPoint and Excel) required, experience with Enterprise Resource Planning (ERP) system (such as SAP) required
Technical writing background/experience is required
Excellent written and verbal communication skills are essential
Attention to Detail: Ability to pay close attention to detail is required
Accuracy: Work is accurate and completeness of records
Outstanding Performance Standards: Demonstrated ability to meet department goals
Communication: Good written and verbal communication skills
Discretion: Acts honest, loyal, trustworthy
Multi-Tasking: Ability to juggle priorities, and support changing business needs
Collaboration: Ability to actively develop a network to bring best solutions to the team or customer
Independence: self-motivated-works under minimal supervision
Professionalism: Must demonstrate professionalism during all interactions within company, customer and third parties
Takes Initiative: Serves as a role model for “Quality First” by continuously improving on what matters most to customers
Problem Solving: Promptly and effectively handles issues and problems

Responsibilities

Assisting in the planning, coordination, control, and continuous improvement of key components of the Quality Management System (QMS).
Ensuring compliance to GMP requirements, FDA & ISO standards, and other regulations as they pertain to the QMS.
Supporting all activities within the Quality Systems team, with primary responsibility for at least one of the following: CAPA process, Deviation process, Internal Audit program, Quality Agreements, Quality Plans, Nonconformance process, Training program.
Tracking, trending of approved CAPAs, and driving timely/appropriate completion of activities, ensuring root cause analysis, actions, verification of effectiveness are appropriate.
Tracking, trending, and driving timely/appropriate closure of deviations, which may include approving and closing deviations.
Planning, conducting, reporting, and transfer of any nonconformities issued to the CAPA process and driving timely/appropriate closure of the internal audit.
Maintaining up-to-date files for Quality Agreements, updating agreements to current template, communicating with affiliates and/or distributors regarding status under minimal supervision.
Issuing numbers, creating plans, tracking status, and ensuring timely/appropriate closure of Quality Plans.
Assisting the Quality Engineering team with tracking, trending, and timely/appropriate closure of the Nonconformance process.
Focusing on improving the competencies of personnel to ensure compliance with regulatory requirements and written procedures by creating and maintaining training materials and delivering training as needed.
Facilitating meetings related to QS activities by taking minutes as directed.
Supporting change orders/process improvements with respect to Quality Management System procedures with direction from management.
Understanding and being aware of the quality consequences which may occur from the improper performance of their specific job; awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities.
Providing support to quality assurance activities for regulatory compliance, (i.e. management review support, regulatory audits).
Assisting with development and maintenance of a variety of metrics pertaining to Quality System activities as assigned, including data for Management Review and KPIs.
Participating in internal, external and/or 3rd party audits, as needed.
Providing support through a general working knowledge of all Accriva Quality System programs.
Aiding employees based on a clear understanding and implementation of Regulatory standards.
Carrying out duties in compliance with established business policies.
Interfacing with all functions and levels of management as needed.
Other duties as assigned, according to the changing needs of the business.