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Senior Quality Engineer Job

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Date: Jan 7, 2021

Location: Spencer, IN, US, 47460

Company: Boston Scientific

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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.


Senior Quality Engineer


About the role:
The Senior Quality Engineer provides focused quality engineering support in a lead role for site, divisional, or global projects. Develops, establishes and maintains quality engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements. Serves as a Quality representative to support departmental, functional, site, divisional and global quality goals and priorities within a collaborative team environment.


Your responsibilities will include:

  • Acts as part of a Core Team (along with Manufacturing Engineer and Supervisor) with responsibility for production unit area(s).
  • Sets a good example for Quality in terms of Patient Care with regard to decision making and prioritization.
  • Provides leadership role in championing departmental or cross-functional engineering initiatives.
  • Provides project direction, coaching, and mentoring for engineering and technical team personnel.
  • Proactively investigates, identifies, and implements best-in-class Quality Engineering practices.
  • Establish effective corrective action plans. Lead in implementation of quality assurance plans, 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.
  • Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues, including FMEA.
  • Review and approve product, process, software qualification and validation and other change control related documentation.
  • Generate internal quality documentation such as quality plans, standard operating procedures and inspection procedures. Ensure BSC regulatory, FDA and ISO compliance in all areas of responsibilities.
  • Must comply with requirements of ISO 14001 and BSC Environmental, Health and Safety standards and follow procedures and instructions related to these standards.


What we're looking for in you:
Basic Qualifications

  • 5+ years’ relevant experience and bachelor’s degree in Quality Engineering or related discipline.
  • 3 - 5 years’ medical device experience.
  • Demonstrated used of Quality tools/methodologies including SPC, DOE, GR&R, FMEA, CAPA, , process validation (IQ, OQ, PQ) and FDA, ISO/MDD standards.
  • Experience leading projects, coaching, and mentoring for engineering and technical team personnel.
  • Demonstrated interpersonal skills with ability to work within a team environment.
  • Strong written/verbal communication skills.

Preferred Qualifications

  • Six Sigma problem solving methodologies, and/or ASQ certification


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: 473245


Nearest Major Market: Bloomington Indiana

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