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Regulatory Document Control Specialist II Job

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Date: May 1, 2019

Location: Arden Hills, MN, US, 55112

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.

 

We currently have an open position at our Arden Hills/St Paul Facility for a Regulatory Document Control Specialist II.  This role will support key internal customers, Cardiac Rhythm Management Research & Development projects as well as strategic projects within the Information Documentation Services department.

Maintains and implements change management system in support of quality systems and practices to meet BSC, customer and regulatory requirements. Serves as a quality representative contact on own area of expertise and to support the manufacturing facility.

 

Key Responsibilities

  • Provide documentation and change management support on a timely and accurate basis.
  • Engineering Change Process:  Process Change Notices in partnership with engineering from creation through completion.
  • Change Management: Collaborate with engineers to plan and prioritize changes. Communicate issues with engineering customers and ensure changes are processed in a timely manner. Ensure changes comply with RM engineering change and documentation policies and procedures.
  • Undertakes specific projects and works on own initiative.
  • Explain and applies RM data management tools (PDM and SAP).
  • Explain and applies concepts from RM Doc Control Policies and Procedures.
  • Train/mentor new Documentation Specialists I.
  • Gathers change metrics and providing reports as required.
  • Interpret and implements Corporate documentation requirements as they relate to Local documentation requirements.
  • Detailed understanding of procedures used within the Documentation Services Group and basic understanding of ISO13485 and GMP requirements.
  • Networking: Serves as resource for product development mapping. Represents the documentation department as needed. Builds relationship with other functional areas and departments.

     

    Quality System Requirements

  • In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
  • Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the BSC Quality Policy.
  • Establishes and promotes a work environment that supports the Quality Policy and Quality System


    Minimum Qualifications

  • Bachelor’s Degree with 1-2 years of relevent  experience
  • Associate’s Degree with 3-5 year of relevent experience.
  • Strong technical writing and communication skills.
  • Ability to work both with others on a project team and independently on tasks.
  • Ability and desire to keep track of work/project details.
  • Ability to work quickly and efficiently on tasks while still maintaining high quality in work.
  • Aptitude to understand engineering and other technical information.
  • Project management and time management skills.
  • Problem solving skills and an ability to respond and adapt to change.

 

  • Preferred Qualifications

  • Experience with Windchill and/or SAP strongly preferred.
  • Medical device industry experience.
  • Knowledge of Lean or Six Sigma.

 

 

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: 445719

 


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