Acelity Careers

Senior Document Control Specialist

San Antonio, United States of America
Quality Assurance


Job Description

This position supports the change order system through creation, tracking, and implementation of Change Orders.  This position has an understanding of Quality System processes and standards, and reviews technical documents for conformance to those standards.  This position is responsible for supporting the control of documents through the electronic system and providing updates to documents that are maintained externally to the electronic system.  This position is responsible for updating all relevant databases including component item set-up and Bill of Material (BOM) configuration in Oracle.

  • Reviews and interprets technical documents for conformance to established standards
  • Creates Engineering and Quality Change Orders per Change Request
  • Tracks and releases Change Orders through implementation
  • Creates Deviations per Change Request
  • Tracks and releases Deviations through implementation
  • Understands and follows Quality System processes relevant to this position
  • Updates electronic databases through the release of Devise Master Record (DMR), Quality System, and non-Quality system documents
  • Manage onsite documents in the document vault
  • Create Items/part numbers in the Oracle Item Master  
  • Create Bills of Materials in the Oracle database from items/part numbers that  provide input to the Master Schedule to drive production demands for purchasing and planning
  • Collaborates with multiple cross-functional departments to include but not limited to Engineering (Franchise teams), Engineering Operations, Design Assurance, external suppliers

Minimum Qualifications:

  • 3 years of Quality Assurance document control experience
  • 1-2 years of data entry experience

Education:

  • High School Diploma
  • Proficiency with Microsoft Office products including: Word, Excel, and Outlook
  • Intermediate knowledge about Good Manufacturing Practices (GMP) and Good Documentation Practices(GDP)
  • Intermediate knowledge of electronic document systems
  • Strong attention to detail and organizational skills
  • Strong verbal and written communication skills

Experiences:

  • Experience using databases, such as updating the Materials Requirements Planning (MRP) system for configuration and item set-up
  • Experience in managing documents in an ISO compliant and FDA regulated environment
  • Quality Inspection or internal auditing experience

Other Qualifications:

  • Proficiency with Microsoft Office products including: Word, Excel, and Outlook
  • Intermediate knowledge about Good Manufacturing Practices (GMP) and Good Documentation Practices(GDP)
  • Intermediate knowledge of electronic document systems
  • Strong attention to detail and organizational skills
  • Strong verbal and written communication skills

Preferred Qualifications: 

  • Associate’s Degree in Business, Engineering Technology, or other related field
  • Ability to build databases using Microsoft Access
  • Experience with Computer Aided Drawing (CAD) software
  • Document control experience in the medical device industry
The information listed above is not a comprehensive list of all duties/responsibilities performed. This job description is not an employment agreement or contract. Management has the exclusive right to alter this job description at any time without notice. Any physical and mental requirements described in this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. EOE AA M/F/Vet/Disability: Acelity L.P. Inc. and its subsidiaries are an equal opportunity and affirmative action employer and give consideration for employment to qualified applicants without regard to race, ethnicity, color, religion, sex, sexual orientation, gender identity, pregnancy, national origin, age, disability, veteran status, or genetic information or any other legally protected characteristic. If you'd like more information about your EEO rights as an applicant under the law, please click here: http://www1.eeoc.gov/employers/upload/eeoc_self_print_poster.pdf VEVRAA Federal Contractor