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Engineer II, Quality Job

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Date: Aug 17, 2019

Location: San Jose, CA, US, 95101

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:

The Quality Engineer II role is an active participant within the Complaint Investigation Site (CIS) supporting Capital Equipment complaints from seven divisions within Boston Scientific. This role is responsible for managing the customer complaint failure analysis process for assigned product families; coordinating additional investigation with Business Unit Quality and/or the Supplied Finished Medical Device Manufacturer (SFMD); investigating trending signals related to product performance; ensuring compliance with policy, procedures, and regulations applicable to Post Market Surveillance complaint handling.

Your responsibilities include:

  • Proactively investigates, identifies, and implements best-in-class Quality Assurance Engineering practices.
  • Participates in customer complaint investigations for capital equipment to identify probable cause and the documentation of findings and maintaining on time closure of complaint investigations
  • Summarizes, analyses, draws conclusions and makes appropriate decisions from test results or other process related findings
  • Become proficient in the use and maintenance of applicable equipment and/or tools
  • Provides Quality Assurance Engineering support to operations to ensure adequate quality system controls and resolve quality issues.
  • Performs analysis and trending of quality data (Complaints, NCEPs/CAPA, Cycle Time).
  • Provides Design Quality Assurance Engineering input to change control processes
  • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving issues such as trend signals
  • Assists in maintaining compliance to BSC Quality system and external regulatory bodies by keeping up-to-date on current regulations and industry standards and by ensuring testing and test method are compliant to the external and BSC standards


What we’re looking for:

Basic Qualifications

  • Bachelor’s degree in an Engineering discipline and 3 years of Quality Assurance Experience
  • Strong communication, writing, editing, and presentation skills. 

Preferred Qualifications

  • Medical device/regulated industry experience.
  • Familiarity with Boston Scientific products, including associated product labeling.
  • Familiarity with Complaint Handling and Quality System processes.
  •  Knowledge of human anatomy/physiology a plus. 
  • Familiarity with EN ISO 14971, ISO 14644, ISO 13485 and CFR/MDD/EU MDR Regulations
  • PC literacy in word processing, spreadsheets, presentation applications, and database management
  • Laser experience a plus
  • Familiarity with Medical Device Capital Equipment is preferred


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: 448977


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

Job Segment: Quality Engineer, Medical, Physiology, Engineer, Engineering, Quality, Healthcare