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Sr QA Documentation Associate Job

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Date: Apr 5, 2019

Location: Cambridge, MA, US, 02138

Company: Boston Scientific

Additional Locations: (n/a)

 

 

Purpose and Passion • Comprehensive Benefits • Life-Work Integration • Community • Career Growth

At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination and a deep caring for human life, we’re solving some of the most important healthcare industry challenges. Together, we’re one global team committed to making a difference in people’s lives around the world. This is a place where you can find a career with meaningful purpose—improving lives through your life’s work.

 

Senior Quality Assurance Documentation Associate

 

About the role:

Responsible for administration of document control activities for the local site.  Supports Quality organization activities including Design Quality Assurance, Quality Systems, and internal audits.

 

Your responsibilities include:

  • Prepares new and revised documents for routing per the local document approval process. Tracks progress in obtaining approvals to for document change notices to aid in timely approvals.
  • Incorporates documentation edits and updates all logs associated with documentation status. Releases approved documents and notifies affected personnel of changes impacting functional areas.
  • Suggests changes to processes documentation and training programs in the spirit of continuous improvement.
  • Supports teams in implementation of quality systems upgrades.
  • Manages the biennial review of documentation system to ensure compliance to standards.
  • Supports internal, regulatory, notified body and corporate audits.
  • Interacts between functional groups in support of Document Change Notices.
  • Facilitates Document Review meeting and makes recommendations as needed to functional areas.
  • Support quality related needs of various departments including Quality Systems, Design Quality Assurance, and R&D.  This includes validation documentation, manufacturing process instructions and quality planning support.
  • Help maintain various spreadsheets and databases for quality systems processes.
  • Update supervisor of work status or problems with recommendations for improvement or correction.

 

What we’re looking for in you:

Basic Qualifications

  • 4 year college degree
  • Ability to work in a fast paced, dynamic environment
  • Team player
  • High energy problem solver capable of driving items to closure

Preferred Qualifications:

  • 2+ years of Medical Device experience

 

About us

As a global medical technology leader for more than 35 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you’re looking to truly make a difference to people both around the world and around the corner, there’s no better place to make it happen.

 

Boston Scientific is an Equal Opportunity Employer – Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Disability, Veteran

 

Requisition ID: 443129

 


Nearest Major Market: Cambridge
Nearest Secondary Market: Boston

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