Document Control Specialist II

Werfen - Bedford - 180 Hartwell Road Bedford, Massachusetts 01730 United States

Country

United States

Shift

1st

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:

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.

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

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…