Document Controller in West Chester, Pennsylvania | DiversityInc Careers
 
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Document Controller


DePuy Synthes, part of the Johnson & Johnson Family of Companies is recruiting for a Document Controller located in West Chester, PA.

 

DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopaedic and neurological business in the world. DePuy Synthes Companies offer an unparalleled breadth and depth of products, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, craniomaxillofacial, power tools and biomaterials. Building on the legacy and strengths of two great companies, more agile and better equipped to meet the needs of today’s evolving health care environment. With a focus on activating insights to develop innovative, comprehensive solutions, we are inspired to advance patient care in greater ways than either company could accomplish on its own.

 

Thriving with a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. We are proud to be an equal opportunity employer.

 

The Document Controller is responsible for control and processing of documentation including but not limited to:

  • Device Master Records, Change Orders/Requests and Change Notices
  • Product, raw material, tool, gauge and fixture drawings
  • Process, setup and inspection sheets
  • Routings, BOMS
  • Text Based Documents
You will:  
  • Maintain Device Master Record Files (product drawings, process sheets, inspection sheets, and applicable manufacturing related documentation).
  • Process manufacturing changes by checking documentation for Good Documentation Practices, assigning document unique identifiers, distributing documents for drafting, and releasing final documents for both electronic and paper systems.
  • Coordinate product and non-product change order activities, including the processing of text-based changes.
  • Control test documentation for new and revised processes and products.
  • Perform accurate data entry in ERP and other Quality Systems.
  • Convert hardcopy quality records to controlled electronic files through a defined electronic archiving process, which includes preparation, processing, and verification of records.
  • Maintain quality records per established Records and Information Management procedures.
  • Assist department in maintaining and improving quality standards and processes. Proactively seek methods to reduce cycle times and drive efficiency in all areas of responsibility on an ongoing basis.
  • Collaborate with production and engineering to ensure compliance with all procedures and QSR standards.
  • Perform other related duties and special projects, as required.
  • Know and follow all laws and policies that apply to one’s job and maintain the highest levels of professionalism, ethics and compliance.
  • Participate in compliance program related activities as denoted by supervisor or Chief Compliance Officer.

Qualifications
  • High School Diploma required.  Associates Degree or higher is preferred.
  • A minimum of 1 year of related administrative experience is required. Manufacturing related experience is preferred.
  • Proficiency in Microsoft Office applications (Word, Excel, PowerPoint, etc.) is required.
  • Demonstrated ability to accurately perform data entry is required.
  • Prior experience with Windchill, ADPATIV, Docusphere, JDE, SAP, or other quality systems is preferred
  • Strong customer service experience and background is required.
  • Knowledge of Quality Systems Regulations is a plus.
  • Excellent organizational and communication skills are required.
  • Proven ability to solve problems relating to Quality Systems and procedures is preferred.
  • Ability to work independently as well as in team environment is required.
  • Must demonstrate high level of initiative with the ability take ownership of special projects and tasks as needed.
  • Ability to self-identify improvement opportunities in the Document Control space is preferred.
  • Ability to form effective partnerships across functional areas is required.
  • Ability to provide customers across multiple functional areas with guidance to resolve Document Control related inquiries is preferred.
  • This position is located in West Chester, PA and requires a daily commute Monday – Friday for the 1st shift working hours of 9 AM – 5 PM with overtime and weekends as required.

Primary Location
United States-Pennsylvania-West Chester
Organization
Depuy Orthopaedics. Inc. (6029)
Job Function
Process Excellence
Requisition ID
7753180724