Document Control Specialist

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  • As an Equal Employment Opportunity Employer, DAVIS has reporting requirements which require us to invite employees to voluntarily self-identify their race/ethnicity. Submission of this information is voluntary and refusal to provided it will not subject you to any adverse treatment. The information obtained will be kept confidential.
  • Accepted file types: pdf, doc, docx, txt, rtf.
  • By applying to this position and providing my contact information, I give The DAVIS Companies permission to provide me with email communications and information.

Document Control Specialist

  • Specialty:

    Manufacturing
  • Title:

    Document Control Specialist
    • City:

      North Billerica
    • State:

      MA
    • Zip Code:

      01862
  • Start date:

    02-05-2019
  • Status:

    Closed
  • Assignment Type:

    Direct Hire
  • Job Id:

    48109

Description

Documentation Control Specialist 

Essential Functions:

  • Ensure compliance with the organization’s policies and all applicable national (FDA 21 CFR Part 820) and international quality standards and regulations (i.e. ISO) regarding Documentation Control. Work with R&D, Manufacturing, Product Support and Marketing to improve product quality to meet current cGMP standards.
  • Develop and maintain standard operating procedures (SOPs). Review ECOs and other documents for accuracy, approve and reject tasks, notify initiator/author when training can be completed. Review and process as needed manufacturing/test procedures for products and raw materials for release into inventory and shipping. Organize and track the training program for all employees.
  • Create and maintain BOMs and item master in XA
  • Maintain records and indexes of all documents stored off-site.
  • Assure all 510(k)s, DHF, Validations and master document files are in a locked, controlled environment, with access limited to Document Control employees and other department officials on an as needed basis.
  • Prepare materials as needed for 3rd party audits and maintain objective evidence documents.
  • Update management with bi-weekly and quarterly metrics as defined by the QA Manager.
  • Other duties as assigned.

Success Factors:

  • Must be able to work with minimal supervision from management. Excellent ability to collaborate to achieve objectives and problem-solve.  Strong knowledge of ISO standards and FDA regulations/guidance as they apply to medical devices.  Understanding of various software programs required to document existing and new documentation.  
  • Able to handle highly confidential messages and correspondence.
  • Must possess outstanding communication (verbal and written), interpersonal, problem solving and customer service skills.
  • Detail-oriented with the ability to work independently as well as collaboratively in a team setting with peers and colleagues in a cross functional setting.
  • Must be self-starter, able to prioritize and handle multiple tasks and ability to meet strict deadlines and perform under pressure in a fast-paced work environment.
  • Good problem solving and troubleshooting skills.
  • Able to read, understand and follow company Standard Operating Procedures (SOPs) and guidelines.
  • Must be able to work overtime and weekends as necessary to support departmental efforts.

Minimum Qualifications / Education:  

  • High school diploma or equivalent (GED) is required. 
  • College education in a business-related field is desirable.
  • 3+ years QA experience with a medical device or IVD manufacturer 
  • 3+ years in a Documentation Control position.
  • Experience with electronic Quality Management Systems a plus.   

Computer Skills:

  • Excellent computer proficiency with Microsoft Office Suite (Word/Excel/PowerPoint/Outlook) 
  • Electronic Quality Management System Software.
  • MasterControl experience is not required but would be beneficial.  
  • Experience with Autocad, Solidworks is a must

Work Environment:     Office

Physical Requirements: Must be able to meet National Institute for Occupational Safety & Health (NIOSH) Standards.

 

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