Senior Quality System Specialist II

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. Overview The Senior Quality Systems (QS) Specialist II is responsible for leading the planning, driving, and strategically advancing major elements of the Quality Management System (QMS) in alignment with GMP, FDA, ISO, and global regulatory requirements. This role serves as a site and cross‑functional subject matter expert (SME) who owns complex quality system processes, leads compliance improvement initiatives, mentors other specialists, and significantly contributes to regulatory inspection readiness and execution. The annual base salary range for this role is currently $120,000 to $150,000. This is a bonus‑eligible position. Individual employee compensation will ultimately depend on factors including education, relevant experience, skill set, knowledge, and particular business needs. Responsibilities Essential Functions CAPA process – track, trend approved CAPAs, and drive timely completion of activities, ensuring root cause analysis, actions, and verification of effectiveness. SCAR process – track, trend approved SCARs, and drive timely completion of activities, ensuring root cause analysis, actions, and verification of effectiveness. Deviation process – track, trend, and drive timely closure; approve and close deviations as needed. Internal Audit program – plan, conduct, report, and transfer nonconformities to the CAPA process; drive timely closure of audit findings. Quality Agreements – maintain up‑to‑date files; update agreements to current templates; communicate with affiliates and/or distributors regarding status under minimal supervision. Quality Plans – issue number, create plan, track status, and ensure timely closure. Training program – improve personnel competencies to ensure compliance with regulatory requirements and written procedures by creating and maintaining training materials and delivering training as needed. Secondary Functions Facilitate and lead meetings related to QS activities. Support and lead change orders/process improvements with respect to Quality Management System procedures with direction from management. Develop and maintain metrics pertaining to Quality System activities, including data for Management Review and KPIs. Participate in internal, external (including regulatory), and/or third‑party audits, as needed. Carry out duties in compliance with established business policies. Provide assistance and recommendations based on a clear understanding and implementation of regulatory standards. Interface with all functions and levels of management as needed. Perform other duties as assigned, according to the changing needs of the business. Networking / Key Relationships All Werfen Departments Werfen Affiliate QARA Werfen Corporate and other Werfen Manufacturer QARA Qualifications Education Minimum of bachelor’s degree in a related scientific or technical field. Experience Minimum 10 years (or 7 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 required. Strong understanding of US FDA Quality System Regulations (QSR), ISO 13485:2016, Good Manufacturing Practices & Good Documentation. Strong computer skills required; expert knowledge of Microsoft Office (Word, PowerPoint and Excel) and experience with an Enterprise Resource Planning (ERP) system such as SAP. Lean/Six Sigma experience, or equivalent certification/education/experience is a plus. Minimal Leadership Skills required. Strong understanding of change control requirements. Strong understanding of record retention. Skills & Capabilities Attention to detail. Accuracy and completeness of records. Outstanding performance standards. Integrity and trust; ability to be discreet. Action orientation – ability to learn on the fly, take initiative, and deliver results. Strong written and verbal communication skills. Honest, loyal, trustworthy disposition. Strong planning, organizational and time‑management skills for multitasking. Collaboration – ability to work with cross‑functional teams. Independence – self‑motivated and ability to work under minimal supervision. Professionalism in all interactions with company, customers and third parties. Drive continuous improvement, correct deficiencies and prevent recurrence. Problem‑solving skills. Travel Requirements 5% of time may be required for travel. Equal Opportunity Statement Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. 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