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Quality Engineer II 1 Job

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Date: Jun 21, 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.

 

Quality Engineer II – Design Assurance

 

About the role:
A Design Assurance Quality Engineer is responsible for assuring all requirements for the Product Development Process (PDP), Risk Management, Design Controls, Usability Testing, and External Manufacturer Production Controls are met within technical development concepts, new product development, operational, sustaining, or system/services support.. Develops, establishes and maintains quality-engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements. Serve as a Quality representative to improve awareness, visibility, and communication on quality initiatives to support assigned departmental, functional, site, divisional and corporate quality goals and priorities.

 

Your responsibilities include:

  • Identifies and implements effective risk management, usability,process and design control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external quality and regulatory requirements.
  • Lead the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements.
  • Act as team member in supporting quality disciplines, decisions, and practices.
  • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
  • Assure the development and execution of streamlined business systems, which effectively and efficiently comply with procedural and regulatory requirements and are robust to identify and resolve quality issues.
  • Support internal and external regulatory audits.
  • Advise management on potential improvements or enhancement to quality systems and processes in the company.

  

What we're looking for in you:

  • Minimum of a BS in Mechanical, Electrical, or Biomedical Engineering.  MS degree preferred.
  • Minimum of 3 years of Medical device design controls and risk management experience required.
  • In depth familiarity with the FDA, ISO, MDD and the medical device industry quality requirements associated with product development and product risk management.
  • Detailed understanding of US and International regulations including 21 CFR, 820, 210, 211, and 11 is required, as well as the Medical Device Directive, EN ISO 13485, EN ISO 14971 and IEC 62366.
  • Strong communication (oral and written) and presentation skills.
  • Familiar with Microsoft Office Suite, and Minitab Statistical Analysis software (or equivalent).
  • Familiarity with process controls, problem solving methodologies, design verification and validation 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: 447907

 


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