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Quality Systems Engineer II Job

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Date: Dec 3, 2018

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 assurance oversight for the Operations Group to ensure compliance with all applicable regulations including documentation reviews, discrepancy system management, audit support, technical, projects, and documentation.

 

Your Responsibilities Will Include:

  • Facilitate development and maintenance of the quality management system according to ISO, EU MDR and FDA requirements.
  • Maintain the CAPA system to ensure proper notification, impact assessment, root cause analysis, investigations and effectiveness verifications are executed, to ensure all requirements are met. In addition, organize and report on CAPA system metrics to management.
  • Act as a Subject Matter Expert in Internal & External Audits; act as a support or lead auditor in the execution of the site internal audit program.
  • Co-ordinate non-manufacturing Training Program, and report on training compliance metrics to senior management.
  • Lead special projects that require Quality Assurance expertise including improvements to quality systems.
  • Perform trending of data and quality systems as it relates to annual reporting, management metrics and other trending, as required.

 

 

What We’re Looking For In You:

Minimum Qualifications:

  • Bachelor's and 2-4 years of relevant industry experience; including experience in the medical device industry

 

Preferred Qualifications:

  • ASQ (or similar) certification preferred
  • Excellent interpersonal skills
  • Strong presentation skills and MS Office skills
  • Experience with major systems (e.g. eCAPA, PDM, CRD, SAP, VIP, Clarizen) desirable
  • Strong analytical and investigation skills
  • Leadership potential

 

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: 439949

 


Nearest Major Market: Santa Rosa
Nearest Secondary Market: Petaluma

Job Segment: Quality Engineer, Medical, Manufacturing Engineer, Systems Engineer, Engineering, Quality, Healthcare