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Quality Engineer II Job

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Date: Sep 6, 2021

Location: Arden Hills, MN, US, 55112

Company: Boston Scientific

Additional Locations:

 

 

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

 

About the role:

Develops, establishes and maintains quality engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements.   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.  Provides focused quality engineering support within new product development, operational, or system/services support.

 

 

Your responsibilities include:

  • 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.
  • Support cross-functional teams to perform assessments and implementation of design changes to existing products.
  • Support internal and external audits and audit responses to existing products.
  • Lead 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.
  • Assure in the development and execution of streamlined business systems which effectively identify and resolve quality issues.

 

What we’re looking for in you:

  • Minimum of a BS in Mechanical, Electrical, or Biomedical Engineering. 
  • Minimum of 3 years of Medical Device design controls and risk management experience required.
  • Familiarity with the FDA, ISO, MDD and the medical device industry quality requirements associated with product design & development and product risk management.
  • Understanding of US and International regulations including 21 CFR, 820, 210, 211, and 11 is required, as well as the Medical Device Directive, EUMDR, EN ISO 13485, and EN ISO 14971.
  • Strong communication (oral and written) and presentation skills.
  • Familiar with Microsoft Office Suite (Excel, PPT, Word), and Statistical Analysis software (Minitab or equivalent). 

 

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

 

Boston Scientific maintains a drug-free workplace.  Pursuant to Va. Code § 2.2-4312 (2000), Boston Scientific is providing notification that the unlawful manufacture, sale, distribution, dispensation, possession, or use of a controlled substance or marijuana is prohibited in the workplace and that violations will result in disciplinary action up to and including termination.

Requisition ID: 475073

 


Nearest Major Market: Minneapolis

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