Senior Quality Systems Specialist I

Introduction 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. Overview Position 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. This position is located out of our Bedford, MA facilities and the anticipated work set up is 4 days onsite and 1 day remote. Responsibilities Key Accountabilities Essential Functions: The Senior Quality Systems Specialist I will be expected to support all activities within the Quality Systems team shown below but will have primary responsibility for maintenance and improvement of 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 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 External Documents – tracking, trending of the External Document process. Driving timely/appropriate initiation and completion of Action Plans. Management Review – Support the creation and delivery of the Management Review presentation. Support completion and approval of the Management Review Meeting Minutes and closure of Action Items. 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. Secondary Functions: Facilitates meetings related to QS activities Supports 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 Participates in internal, external (including regulatory) and/or 3rd party audits, as needed Carries out duties in compliance with established business policies Provides assistance and recommendations based on a clear understanding and implementation of regulatory standards Interfaces with all functions and levels of management as needed Other duties as assigned, according to the changing needs of the business Networking/Key relationships To be determined based on department needs, to include interactions such as: All IL Departments Werfen Affiliate QARA Werfen Corporate and other Werfen Manufacturer QARA Skills & Capabilities: The ideal candidate for this position will exhibit the following skills and capabilities: Attention to Detail : Good ability to pay close attention to detail is required Accuracy : Work is accurate and completeness of records Outstanding Performance Standards : Demonstrated good ability to meet department goals Ethics and Values: Integrity and Trust / Ability to be Discrete Delivery of Results (Action Orientation) : Good ability to Learn on the Fly / Taking Initiative Communication : Good written and verbal communication skills Discretion: Acts Honest, Loyal, Trustworthy Multi-Tasking : Good planning, organizational and time management skills are required to support changing business needs Collaboration : Good ability to work with cross functional teams Independence : Must be self-motivated and have the ability to work under minimal supervision; must also be able to work as part of a team Professionalism : Must demonstrate professionalism during all interactions within company, customer and third parties Takes Initiative : Good ability to drive continuous improvement, correct deficiencies and to prevent recurrence Problem Solving: Good problem-solving skills are required Additional Skills/Knowledge: Previous Quality Assurance experience within a GMP regulated environment required. Good understanding of US FDA Quality System Regulations (QSR), ISO 13485:2016, Good Manufacturing Practices & Good Documentation. Good computer skills required; expert knowledge of Microsoft Office (including Word, PowerPoint and Excel) required, experience with Enterprise Resource Planning (ERP) system (such as SAP) required. Good understanding of change control requirements. Good understanding of record retention. Qualifications Minimum Knowledge & Experience Required for the Position: Education : Bachelor's degree or equivalent in engineering or science Experience: A minimum of 8 years of experience in medical devices, pharmaceuticals, diagnostic industry, or clinical laboratory or 5 years of experience with an advanced degree Additional Skills/Knowledge: Duties necessitate broad and thorough knowledge of engineering and science theory and principles, including R&D, quality control, manufacturing and design engineering Understanding of the application of technical principles and engineering problem solving to resolve complex issues. ASQ Quality Engineering Certification - Desirable LEAN/Six Sigma Certification - Desirable International Mobility: Required: No Travel Requirements: Approximately 10% of time The annual base salary range for this role is currently $115K to $140K. Individual employee compensation will ultimately depend on factors including education, relevant experience, skillset, knowledge, and particular business needs. This role is eligible for medical, dental, and vision insurance, 401k plan retirement benefits with an employer match, as well as paid vacation and sick leave. Our sales roles are eligible for participation in a commission plan and our management, and select professional roles, are eligible for a performance-based bonus. Closing 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 [email protected] 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