Document Control Specialist II

Werfen - Bedford - 180 Hartwell Road Bedford, Massachusetts 01730 United States Country United States Shift 1st About the Position 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 facilitating, coordinating and processing change orders. This person may be responsible for drawing work, including Pro E and Auto CAD, Windchill interface. Determines how to improve and maintain the change control system and associated processes by means of lean and operational excellence activities. Acts as the primary interface between engineering, manufacturing, field service, marketing, etc. to ensure the appropriate changes are properly documented and implemented. Manages the quality manual system document facilitation working cross functionally. Manages activities such as periodic review and validation expirations. Responsibilities Key Accountabilities: Highly knowledgeable on the change order process, trains and guides customers and staff as needed. Facilitating, coordinating and processing change orders. Manages software submissions and owns the control and integrity of the software library. Resolves and manages complex Routings, QA routings and QC routings. Develops SAP BOMs for assemblies, Printed Circuit Boards (PCBs) with reference designator and BOM allocation. Knowledgeable with alternate BOMs, Material Master Maintenance. May generate basic models, 3-D models and drawings using engineering design/drafting software (i.e. Autocad, Creo, Microsoft Word, Excel, Visio, Adobe Acrobat. Management of cross plant and multi plant change orders and control of documents. Provides expert assistance with technical aspects of Change Orders, including material disposition, material master attributes, bill of material assistance, and implementation of follow-up actions required. Ensures that existing change order procedures and Documentation Standards are followed and adhered to. May manage the periodic review program. Works cross functionally to make determinations on document status; records activities and ensures identification is completed. May manage the maintenance of validation expirations.Follows up monthly with cross functional members for validation protocol closure. Subject Matter Expert for the Quality Manual documentation team. All other duties as assigned by manager Budget Managed (if applicable) N/A Internal Networking/Key Relationships To be determined based on department needs Skills & Capabilities: Oral and Written Communications, Action Oriented; Organization, Team Work Qualifications Minimum Knowledge & Experience Required for the Position: Bachelor's degree, preferably in Business or technical discipline, or equivalent. Minimum of 3 years in a document management and/or change order environment. Knowledgeable in the Change Order SAP tool. Fluently understands the CO initiation process and its requirements. Experience in mechanical drafter/designer utilizing engineering drafting and design software a plus. Possesses a high level understanding of how changes will affect compliance of documents, drawings, BOMs, system records, etc. Strong written and verbal communication. Minimum of 5 years of related experience in Operations, Quality, or R&D areas. International Mobility: Required: no Travel Requirements: May travel occasionally to support the Orangeburg site The annual base salary range for this role is currently $80,000 to $100,000. 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. 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 View email address on click.appcast.io 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. #J-18808-Ljbffr Werfenlife SA.