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Documentation Clerk III Job

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Date: Jan 30, 2019

Location: Santa Rosa, CA, US, 95403

Company: Boston Scientific



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.


About the Role:

Provide quality systems expertise to ensure adherence to regulations, company policies, and internal procedures in all phases of product life cycle with particular focus on documentation and configuration management, quality record archival and maintenance, employee training, quality system integration, and external standards.



Your Responsibilities Will Include:

  • Administer, improve, and maintain the company’s Document Control and Training
  • Management Systems. Lead integration of documentation and record control systems into quality management software modules
  • Create and maintain all controlled document files, both hard copy and electronic versions, including associated logs. Maintain security controls on all documents
  • Manage and track quality system employee training program
  • Manage documentation revision related to reviewing and writing policies, procedures, assembly instructions, and other controlled documents
  • Review manufacturing documentation of in-process work, incoming materials, and finished goods in the manufacture of medical devices
  • Collect and trend quality metrics in the areas of document change requests, training compliance, etc. in support of Management Review meetings
  • Create quality reports and make recommendations for improved reporting
  • Audit quality records
  • Train staff on proper procedures and document policies as needed
  • Adhere to general safety rules, manufacturing procedures, company policies and procedures, Good Manufacturing Practices, ISO / MDD, and FDA regulations
  • Complete projects consistent with corporate objectives
  • Support company goals and objectives, policies and procedures, Good Manufacturing
  • Practices, ISO/MDD and FDA regulations
  • Perform internal quality audit activities and ensure proper follow-up/closure
  • Lead or participate in quality system improvement projects and corrective actions, as required
  • Provide support for ISO and FDA audits
  • Work overtime, as necessary
  • Perform other duties, as assigned



What We’re Looking For In You:

Minimum Qualifications:

  • High school diploma is required. Bachelor’s Degree is preferred. In the absence a Bachelor’s Degree, related experience may substitute.
  • 5-7 years of medical device quality system experience as well as MDD/ISO 13485 and/ or GMP System experience or equivalent.
  • ISO 13485 Quality System Training
  • Strong organizational skills.
  • Strong communication skills, both verbal and written.
  • Good computer skills including word processing and spreadsheets.
  • Ability to utilize basic math skills.


Preferred Qualifications:

  • ERP System (e.g. IQMS)
  • ISO 13485 Lead Auditor Training


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: 439951


Nearest Major Market: Santa Rosa
Nearest Secondary Market: Petaluma

Job Segment: Clerical, Medical, Quality Manager, Medical Technology, Administrative, Healthcare, Quality