Senior Document Control Specialist

1 month ago

Carlsbad, United States Orthofix Full time
Job Description

At Orthofix, we are seeking a highly skilled Senior Document Control Specialist to join our team. As a key member of our Quality Management team, you will be responsible for ensuring the accuracy and completeness of our documents and records.

Key Responsibilities:

  • 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.
  • 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.

Requirements:

  • 5+ years' experience within Document Control.
  • 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.

Preferred Qualifications:

  • Bachelor's degree preferred.
  • 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:

  • 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.

Salary:

The anticipated salary for this position for an employee who is located in California is $57,000 to $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, ethnicity, religion, color, sex, gender, gender identity or expression, sexual orientation, national origin, ancestry, citizenship status, uniform service member and veteran status, marital status, pregnancy, age, protected medical condition, genetic information, disability, reproductive health decision-making, medical leave or other types of protected leave, 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.

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