What are the responsibilities and job description for the Compliance Specialist II position at Werfen?
WerfenWerfen 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 : Responsible for release of product to Market and management of device history records. Supports manufacturing in document and quality related issues. Supports QA in SAP functions. Provides metrics regarding OHR review for management review and driving improvement. Maps process and devises new tools to help drive compliance and streamlining of system under direction of management.Key Accountabilities : Reviews of device history records for release of product to Distribution, including training Manufacturing, Materials and QC personnel in Good Documentation Practices.Provides statistics regarding device history record accuracy for all manufacturing teams and Management Review.Dissemination of product Certificates of Analysis to all points of distribution.Organizes and maintains the Device History Records.Organizes quarterly trainingBudget Managed (if applicable) : N / AInternal Networking / Key Relationships : To be determined based on department needsSkills & Capabilities : Excellent communication and training skillsMin Knowledge & Experience Required for the Position : Bachelor's Degree in a scientific discipline or equivalent with minimum 2 years of related Quality Assurance experienceWorking knowledge of ISO Quality Systems and FDA requirements for the Medical Devices Industry;Computer literacy including SAP, Excel and PowerPointUnderstanding of the principles, theories and concepts related to the manufacture and support of Medical DevicesInternational Mobility : Required : NoTravel Requirements : NoIf 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.comMinimum Salary : 80000 Maximum Salary : 100000 Salary Unit : Yearly
