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Technician II, Quality Job

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Date: Dec 4, 2018

Location: Los Gatos, CA, US, 95032

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.

 

About the role:

Perform quality activities to support manufacturing and sustaining of existing products. Provide quality support to appropriate groups: engineering, manufacturing, quality, microbiology and design assurance, system/services, incoming/line/final inspection and post market, etc. Develop, apply, monitor, measure, document, improve, and communicate quality methodologies from prodcut development through end of life of a product.

 

Your responsibilities include:

  • Co-ordinate and ensure routine testing including bioburden, LAL, environmental monitoring, sterility and particulate testing are performed according to standard operating procedures.
  • Performs data collection and analysis to monitor trends in test results.
  • Interfaces between outside testing laboratories and representatives from other departments, for various quality activities
  • Support Quality department in identification, segregation, disposition and documentation of non-conforming product.
  • Help Investigate and correct errors in any aspect of quality process by working with other functions
  • Perform Product Record Review (DHR, Risk, Labeling, and other records)
  • Educate production team on quality control issues and work with departmental managers to improve overall company safety and product quality
  • Ensure that all of the quality check procedures put in place by the company are followed during manufacturing
  • Assists with regulatory audits at the site
  • Possess good written and verbal communication skills
  • Train and document training related to all job related tasks on a timely manner using electronic training and documentation systems
  • Possess good organization skills and able to multi task

 

What we’re looking for:

Basic Qualifications

  • High school Diploma or combination of education and experience
  • Must have intermediate computer skills to use a computer with Windows 7 (or higher) and is familiar with MS Word and Excel
  • Must be detailed oriented and quality minded

 

Preferred Qualifications:

  • AA degree in engineering or technical discipline Or 2 years of experience in a quality role (medical device preferred)
  • Familiarity with FDA regulations related to medical devices including DHR, GDP, GMP, Complaint Handling, etc.
  • General understanding of GMP and ISO 13485 guidelines
  • Able to use lab equipment (DMMs, Oscilloscopes, Microscopes, custom test fixtures and gauges)

 

 

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: 440049

 


Nearest Major Market: San Jose
Nearest Secondary Market: Palo Alto

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