Quality Systems Specialist III

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.

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.

Key Accountabilities

Essential Functions:

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

• CAPA process - tracking, trending of approved CAPAs, and driving timely/appropriate completion of activities, ensuring root cause analysis, actions, verification of effectiveness are appropriate
• Deviation process - tracking, trending, and driving timely/appropriate closure. This may include approving and closing deviations.
• Internal Audit program - planning, conducting, reporting, and transfer of any nonconformities issued to the CAPA process and driving timely/appropriate closure of the audit.
• Quality Agreements - maintaining up-to-date files, updating agreements to current template, communicating with affiliates and/or distributors regarding status under minimal supervision
• Quality Plans - issuing number, creating plan, tracking status, timely/appropriate closure
• Nonconformance process - assisting Quality Engineering team with tracking, trending, and timely/appropriate closure
• Training program - 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.

Quality Systems Activities:

• CAPA
• Deviation process
• External Document process
• Internal Audit program
• Nonconformance process
• Quality Agreements
• International QMS compliance with Werfen Affiliates
• Quality Plans
• Training program

Skills & Capabilities:

• Helps facilitate meetings related to QS activities by taking minutes as directed
• Supports change orders/process improvements with respect to Quality Management System procedures with direction from management
• Understands and is aware of the quality consequences which may occur from the improper performance of their specific job; has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities
• Provides support to quality assurance activities for regulatory compliance, (i.e. management review support, regulatory audits)
• Assist with development and maintenance of a variety of metrics pertaining to Quality System activities as assigned, including data for Management Review and KPIs
• Participates in internal, external and/or 3rd party audits, as needed
• Provides support through a general working knowledge of all Accriva Quality System programs
• Aids employees based on a clear understanding and implementation of Regulatory standards
• Carries out duties in compliance with established business policies
• Interface with all functions and levels of management as needed
• Other duties as assigned, according to the changing needs of the business

Minimum Knowledge & Experience Required for the Position:

• 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

Technical Qualifications:

• 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

Competencies:

• 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

If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV.

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. If you have a disability and need an accommodation in relation to the online application process, please contact NAtalentacquisition@werfen.com for assistance.

We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7,000 employees around the world comprise our Werfen team.

www.werfen.com