Senior Document Control Specialist

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?

Perform clerical and computer duties necessary to process, distribute, and maintain documents and records within the Quality Management System. Support the development, implementation, and maintenance of document control and record maintenance systems necessary to comply with related domestic and international laws, regulations, and standards.

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.

• 5+ years' experience within Document Control

• Document management: including, but not limited to approval, change, access, distribution, notification, and administration of training.

• Records management and disposition.

• Provide primary change analyst support for Engineering Change Orders and Manufacturing Change Orders.

• Assign items to other Oracle organizations as required.

• Set-up and maintenance of approval lists / electronic process workflows.

• Provide secondary support for label development and management.

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.

Education/Certifications:

• High School Diploma or equivalent

Experience, Skills, Knowledge and/or Abilities:

• Working knowledge of Microsoft Office and Adobe products.

• Must have good written and verbal communication skills.

• Detail-oriented: work must be accurate and complete.

• Ability to react quickly and positively to priority changes as required by the needs of internal customers.

• Ability to work well individually and with others.

• Must have basic clerical skills such as filing, copying, faxing, and scanning.

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:

• Bachelor's degree preferred

Additional Experience, Skills, Knowledge and/or Abilities:

• Knowledge of Oracle, Agile PLM, and/or enLabel IPM, is a plus.

• Knowledge of medical device (FDA 21 CFR Part 820) or equivalent (e.g., ISO 9001, etc) formal document control and record systems.

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.

• This position requires frequent or continuous sitting and/or standing.

• This position requires frequent or continuous walking.

• This position requires frequent or continuous moderate lifting of 15-40lbs.

The anticipated salary for this position for an employeewho is located in Californiais$57,000to$74,000 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.