Share this Job

Supplier Quality Engineer II - Defined Term Job

Apply now »
Apply now

Apply for Job

Date: Jun 27, 2019

Location: Marlborough, MA, US, 01752

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.


Please note this is a defined term position of approximately 1 yr. duration. Defined term employees are eligible for most benefits including paid vacation, holidays, 401k matching and healthcare benefits.


About this role:

This is a critical leadership role working to align supplier specifications to meet requirements of EU MDR.

Provides focused Supplier Quality Engineering support for the procurement of products and services to Boston Scientific. Develops, establishes and maintains Supplier Quality Engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements. Serves as a Quality representative to improve awareness, visibility, and communication on quality initiatives to support departmental, functional, site, divisional and corporate quality goals and priorities.

Your responsibilities include:

  • Plans and conducts scheduled audits of suppliers to assess compliance with Boston Scientific requirements.
  • Performs assessment of supplier capabilities through desktop assessment, direct on-site visits, and technical discussions.
  • Conducts and confirms follow-up actions on Supplier Quality System Audits. 
  • Communicates quality issues to suppliers as needed and helps develop corrective actions.
  • Tracks and trends supplier performance, taking remedial action as needed.
  • Generates Supplier Performance Reports.
  • Maintains accuracy of Vendor Audit Report and Supplier Profile Reports.
  • Provides guidance to Purchasing and Engineers in applying Supplier Quality system requirements.
  • Reviews, understands, and implements updates related to BSC Policy changes. Includes incorporation of this information into corporate and divisional programs through document reviews, protocol reviews, validation reviews, and training programs.
  • Processes supplier change impact assessments through cross functional team
  • Primary relationship owner with supplier providing feedback as warranted to ensure compliance and alignment of BSC and supplier specifications.

What we’re looking for in you:

Minimum Qualifications

  • 2-5 years’ experience in Manufacturing or Quality with a Bachelor’s degree Engineering or related technical discipline.
  • 0-3 year experience with a Master’s degree in Engineering or equivalent medical device industry experience.
  • Excellent written and verbal communication skills
  • Working knowledge and understanding of FDA, ISO13485, and the medical device industry quality requirements associated with manufacturing and supplier controls
  • Demonstrated ability to identify and work with cross functional organizations to solve problems
  • Strong command of MS Office – Word, Excel, Powerpoint, Visio
  • Ability to rapidly learn and use new applications

Preferred Qualifications

  • Previous experience Supplier Quality, Quality Engineering, or Manufacturing background.
  • Experience in the medical device industry
  • Lead auditor certification ISO 13485 and previous auditing experience.
  • Experience in problem solving and process improvement methodologies
  • Process Validation, Risk Management, NCEP, CAPA experience


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: 441448


Nearest Major Market: Boston

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