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Quality Engineer II - Defined Term Job

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Date: May 3, 2019

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.


** This is a 12-month Defined Term position


About the Role

Works in conjunction with and takes technical direction from a Quality Engineer or Senior Quality Engineer on site with a defined responsibility within a specific area of expertise/technology, product line or project team.  Demonstrates commitment to the Quality Policy (patient safety and product quality) through their daily execution of sound quality practices and the maintenance of an effective quality system. Understands and complies with all the regulations governing the quality systems. Ensures their direct reports are aware of their commitment to patient safety and product quality, are current with their training requirements and that they understand and comply with all other regulations governing their work.  Responsible for providing Quality Engineering input to support Manufacturing, Manufacturing Engineering, Operations and R&D activities. Develops, establishes and maintains quality engineering methodologies, systems, and practices which meet BSC-SH, customer, and regulatory requirements. Supports new product development and design change projects, as required.  Serves as a Quality representative to improve awareness, visibility, communication on quality initiatives to support departmental, functional, site, divisional and corporate quality goals and priorities.  Some support with new product development may be required as needed.


Your responsibilities will include:

  • Assists to define and implement all Quality standards and specifications and helps to ensure that Corporate and Regulatory requirements are met.
  • Identifies and resolves moderately complex exceptions to work assignments.
  • Summarizes, analyses and in conjunction with additional engineering support draws conclusions and makes appropriate decisions from test results on other process related findings.
  • May participate directly in a new product/technology transfer project or product development project to gain the necessary experience/exposure which such a challenge presents.
  • Always aims to be a leader of quality QSR and ISO/MDD standards, constantly promoting excellence within ones own group.
  • Uses knowledge of Six Sigma, Statistical Analysis and Lean principles to investigate and solve problems and improve quality.
  • Will be broadly conversant with Validation/Design Verification and Design Validation techniques and associated Regulatory requirements including analysis of customer feedback and complaints, as required.
  • Understands and proactively follow through on the Environmental Management Procedures that have been identified as relevant to position.
  • Is a good team member, fully motivated to achieve and demonstrate best practices in line with the department and Site objectives.
  • Support Failure Mode and Effects Analysis or Product Risk Management activities, as required by role.
  • Ability to develop test methods and test equipment implementation (including procurement, qualification, and calibration) to support new product development initiatives, if required by role.
  • Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements.
  • Participate in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements.
  • Acts as an effective leader or team member in supporting quality disciplines, decisions, and practices.
  • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
  • Support and/or drive corrections and corrective actions to resolve non-conformances.
  • Routinely interfaces with Engineers, Technicians, Operators, and suppliers on Quality related issues.
  • Support internal and external audits as needed.
  • Ability to work on multiple project tasks and assignments based on organizational needs.
  • Train and mentor others as needed.
  • Develops, establishes and maintains calibration programs, policies, processes, procedures and controls ensuring conformance to established standards and guidelines.
  • Provides guidance and approval regarding calibration strategies and approaches. Provides expert guidance in determining appropriate equipment and appropriate specifications.  Writes calibration procedures.
  • Reviews, analyzes and reports on calibration related discrepancies.  Develops corrective actions plans and facilitates completion.  Interfaces with manufacturing, engineering, quality, R & D, customers and suppliers to develop solutions and corrective action plans.
  • Ensures calibration procedures include specific direction and limits for accuracy and precision.  Ensures calibration procedures include provisions for handling, preservation, and storage of equipment so that accuracy and fitness for use are maintained.
  • Works with Quality Compliance to ensure that inspections, statistical process control analyses and internal audits are conducted on a continuing basis as specified to enforce requirements and meet specifications.
  • Acts as calibration Subject Matter Expert in support of external audits by regulatory agencies and notified bodies, as required.
  • Completes and/or assists in identifying and developing department tools and methodologies. Creates calibration reports and provides data for metrics reporting.
  • Provides internal customer training on calibration procedures and policies.
  • Acts as back-up for hands-on calibration and document review activities when required under emergency situations.


What we’re looking for in you:

Basic Qualifications

  • Bachelor’s degree in Engineering or Scientific Discipline
  • Understanding and demonstrated experience in Process Validation (IQ, OQ, PQ)
  • Demonstrated interpersonal skills with ability to work within a team environment.
  • Strong written/verbal communication skills.

Preferred Qualifications

  • Six Sigma problem solving methodologies



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: 444475


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

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