Senior Change Analyst

Werfenlife SA.; New York (NY); On-site; USD 100,000 - 120,000; Full time

Job summary

Werfen is hiring a Change Order/Change Control professional to coordinate Change Orders meetings and maintain the Change Control System. You will serve as the primary interface between engineering, manufacturing, field service, marketing, and other groups to ensure changes are properly documented and implemented.

The role requires a Bachelor's degree and 5–10 years in Operations, Quality, or R&D, plus experience with electronic change control systems and ERP interfaces.

Qualifications

• Bachelor's Degree or equivalent and minimum 5 years of specific experience.
• Proven background with electronic change control systems and ERP interfaces.
• 10 years of related experience in Operations, Quality, or R&D areas.

Responsibilities

• Facilitates and assist with Change Order creation, planning and implementation.
• Tracks and coordinate Change Order development, approval, and implementation.
• Provides expert assistance with technical aspects of Change Orders, including material disposition and follow-up actions.
• Ensures Change Order procedures and Documentation Standards are followed.
• Interfaces with all departments involved in Change Order processes.
• Supports Change Control Board reviews and checks.
• Creates and maintains Change Order metrics to reduce cycle time.
• Develops reporting mechanisms from electronic Change Control systems.
• Administers systems and coordination within Configuration Management.

Skills

Change orders

ERP systems

Education

Bachelor's Degree or equivalent

10 years related experience in Ops/QA/R&D

Tools

Electronic Change Control Systems

ERP integration

Job description

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 and coordinating Change Orders meetings. Determines how to improve and maintain the Change Control System and associated processes. Acts as the primary interface between engineering, manufacturing, field service, marketing, etc. to ensure the appropriate changes are properly documented and implemented.

Responsibilities

Key Accountabilities

Essential Functions:

• Facilitates and assist with Change Order creation, planning and implementation.
• Tracks and coordinate Change Order development, approval, and implementation.
• Provides expert assistance with technical aspects of Change Orders, including material disposition, field proliferation and implementation of follow-up actions required.
• Ensures that existing Change Order procedures and Documentation Standards are followed and adhered to.
• Checks Change Orders for Completeness, Accuracy and Consistency.
• Interfaces with and assists all other departments involved in Change Order process as required.
• Assists Change Control Board with Review and Checking of Change Orders to support their approval of Change Orders.
• Creates and maintains Change Order metrics focused on cycle time reduction process enhancement.
• Creates of reporting mechanisms derived from electronic systems interaction related to Change Control functions.
• Administrative duties related to systems and employee coordination in the Configuration Management arena.
• 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:

• Functional/technical skills

The annual salary range Werfen reasonably expects to pay for the position is $100,000 to $120,000. Compensation is reasonably based upon multiple factors including education, relevant experience, skillset, knowledge, and specific needs of the business.

Qualifications

Minimum Knowledge & Experience Required for the Position:

• Bachelor's Degree or equivalent. Minimum of 5 years of specific experience.
• Proven background with electronic change control systems and their interface with ERP systems
• 10 years of related experience in Operations, Quality, or R&D areas.

International Mobility: Required:

• no

Travel Requirements:

• No

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 [e-mail] 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.