Senior Document Control Specialist

Job Summary

Responsible for the accurate preparation, documentation, and distribution of all Quality System documentation, labeling and records. Responsible for leading additional Document Control team members as applicable.

Essential Job Functions

• Support Document Control department and activities per Quality Management System processes for multiple business units.
• Establish and maintain all label and IFU documentation for multiple business units.
• Establish and continuously improve Document Control methods and management tools.
• Ensure compliance to internal QMS documentation and FDA CFR 820, and ISO 13485 as required.
• Demonstrate effectiveness of Document Control activities to internal and external auditors and inspectors as required; will need to serve as a subject matter expert.
• Maintain a computer database of all filed documentation that ensures fast retrieval of documents
• Maintain the flow of both electronic and hard-copied controlled documents, department files and resource materials
• Timely distribution of latest revision level documentation to all appropriate users and ensure that obsolete documentation is removed from distribution
• Maintain Master Document Control Log and Files
• Review change orders and for completeness and accuracy
• Edit and assist in drafting new Quality System Procedures
• Support the Quality Department objectives and goals by participating in Quality projects when needed
• Assist with CAPAs as required

Qualifications

Required:

• Minimum 5 years working in Document Control within a Medical Device Quality Management System
• Minimum 1 year of experience working with metrics/data analytics
• Associate’s degree or equivalent appropriate industry experience

Preferred:

• ISO 13485 experience
• FDA regulated medical device experience 21CFR820
• Knowledge of Master Control software

Competencies

• Ability to perform word processing and create basic spreadsheets, as well as work in Adobe and numerous on-line media
• Ability and willingness to learn/use new software programs
• Ability to communicate effectively (both written and verbal)
• A high attention to detail and orderly focus
• Background in editing or documentation management
• Can follow instructions
• Will be a pro-active problem solver
• Work to maintain efficiency and quality balance in your work
• Team player
• Good communicator

Physical Requirements

Performing the duties of this job regularly involves: (1) sitting, (2) standing; (3) walking; (4) hearing/listening (5) repetitive hand movement; (6) grasping; (7) reaching; (8) lifting; (9) carrying; (10) bending/stooping; (11) vision requirements - close vision, adjust focus, color code; (12) other.

Mental Requirements

This position requires the ability to: (1) maintain an appropriate work pace; (2) comprehend and follow instructions; (3) exercise logic and reasoning; (4) organize and prioritize; (5) read; (6) compose written communication; (7) communicate verbally; (8) problem solve (9) make decisions; (10) count and compute (11) analyze and interpret data; (12) multi-task/re-direct; (13) experience numerous interruptions, (14) This position requires the ability to maintain the highest standards of professional maturity and emotional intelligence even in difficult or stressful situations; (15) other

Other Requirements

Minimal travel (less than 10%)

Work Environment

The noise level in the work environment is usually quiet to moderate.

Safeguard Medical is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to a work environment that supports, inspires, and respects all individuals and in which personnel processes are merit-based and applied without discrimination based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.

Safeguard Medical believes that diversity and inclusion among our teammates is critical to our success as a global company, and we seek to recruit, develop, and retain the most talented people from a diverse candidate pool.