Oracle Fusion QMS Administrator

Why Orthofix?

We are a leading global spine and orthopedics company with a premier portfolio of biologics, innovative spinal hardware, bone growth therapies, specialized orthopedic solutions and a leading surgical navigation system. Our combined company is over 1,600 strong, with products distributed in 68 countries worldwide and a global R&D, commercial and manufacturing footprint, and this is just the beginning!

Come join our global team of dedicated professionals who through their extraordinary efforts demonstrate every day their commitment to our mission of improving the lives of patients. At SeaSpine and Orthofix our culture is built around Integrity and the core beliefs we live by: Exceed Expectations, Work Together, Be Respectful, Get Lean and Have Fun!

How you'll make a difference?
The Oracle Fusion QMS Administrator is responsible for management and support of the Quality Management and Product Development modules within Oracle Fusion. The administrator will manage user lifecycles and access role privileges including user set-up and maintenance as well as configuration updates, mass data import maps and is the champion for continuous improvement in the Fusion QMS application.

What will your duties and responsibilities be?
The following are the essential functions of this position. This position may be responsible for performing additional duties and tasks as needed and assigned.

• Work cross functionally with Quality, Document Control, Product Development and Regulatory departments to perform basic application support functions and trainings.

• Lead weekly change approval board (CAB meetings) to review open Jira ticket requests for change requests to the Oracle Fusion QMS application.

• Support the new product introduction stage gate process including assisting users with importing of data for batch processing (import maps).

• Provide guidance and controls for the accurate set-up and validation of product data in Oracle Fusion product development module.

• Understand and update Fusion configurations, validations, list values and multi select fields.

• Understand and experience working with Fusion batch processing and Import Maps

• Understand and experience working with User Roles, User Groups, Privileges (User Access Controls)

• Understand regulated controlled processes and how they impact item attribute changes and revision levels in Fusion and ERP.

• Work with IT developers on project initiatives for Fusion QMS enhancements and integrations of QMS with ERP.

• Assist with troubleshooting and resolution of Fusion QMS to Oracle ERP interface errors

• Support the Processing of Change Orders within the Fusion QMS system

• Support data extracts and reporting of Fusion product data, change orders, quality issues and actions.

• Support testing and quarterly validation activities related to changes made by Oracle software release updates as well as Orthofix initiated changes.

What skills and experience will you need?
The requirements listed below are representative of the education, knowledge, skill and/or ability required for this position.

• Bachelor's degree from an accredited college/university is preferred or equivalent experience.

What qualifications are preferred?
The education, knowledge, skills and/or abilities listed below are preferred qualifications in addition to the minimum qualifications stated above.

Education/Certifications:

• Oracle certification – Fusion Quality Management or Product Development

Additional Experience, Skills, Knowledge and/or Abilities:

• Experience with systems validations in a Medical Device environment

• Experience with Hitachi SCMnet

• Experience working with integration to Oracle ERP

  • Items, BOMs, Change Orders, Revisions

  • Oracle ERP Engineering and Inventory modules

PHYSICAL REQUIREMENTS / ADVERSE WORKING CONDITIONS

The physical requirements listed in this section include but are not limited to the motor/physical abilities, skills, and/or demands required of the position in order to successfully undertake the essential duties and responsibilities of this position. In accordance with the Americans with Disabilities Act (ADA), reasonable accommodations may be made to allow qualified individuals with a disability to perform the essential functions and responsibilities of the position.

• No additional physical requirements or essential functions for this position.

The anticipated salary for this position is $107,000 to $130,000 per year, plus bonus, and benefits.

DISCLAIMER

The duties listed above are intended only as representation of the essential functions of this position. The omission of specific statements of duties does not exclude them from the position if the work is similar, related, or a logical assignment to the position. The job description does not constitute an employment agreement between the employer and employee and is subject to change at the sole discretion of the employer. Nothing in this document alters an employee’s at-will employment status.

We are committed to providing equal employment opportunities to all employees and applicants without regard to race (including traits historically associated with race, such as hair texture and protective hairstyles, including braids, locks, and twists), ethnicity, religion, religious creed (including religious dress and grooming practices), color, caste, sex (including childbirth, breast feeding, and related medical conditions), gender, gender identity or expression, sexual orientation, national origin, ancestry, citizenship status, uniform service member and veteran status, marital status, pregnancy, age (40 and over), protected medical condition (including cancer and genetic conditions), genetic information, disability (mental and physical), reproductive health decision-making, medical leave or other types of protected leave (requesting or approved for leave under the Family and Medical Leave Act or the California Family Rights Act), domestic violence victim status, political affiliation, or any other protected status in accordance with all applicable federal, state, and local laws.

This policy extends to all aspects of our employment practices including, but not limited to, recruiting, hiring, discipline, termination, promotions, transfers, compensation, benefits, training, leaves of absence, and other terms and conditions of employment.