Document Control Specialist II

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 7000 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. Were 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:

• Bachelors 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 $80000 to $100000. 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 sales roles are eligible for participation in a commission plan and our managementand select professional rolesare eligible for a performance-based bonus.

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 individuals 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 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 7000 employees around the world comprise our Werfen team.