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Quality Manager I - Design Assurance

Boston Scientific's hybrid workplace includes remote and onsite roles. By applying to this position, you will have the opportunity to discuss your preferred working location with your Talent Acquisition Specialist.

Remote Eligible:  Hybrid
Onsite Location(s): 

Marlborough, MA, US, 01752

Hiring Manager: Amie Lynn Preston
Recruiter: Spencer Gregory Hale

 

The Quality Manager I - Design Assurance provides leadership and guidance to the new product development and sustaining engineering teams with a focus on identifying and meeting the quality goals for the SUO portfolio within the Endoscopy division.  

 

Your responsibilities will include:

  • Manages and leads the quality engineering team by providing coaching, ongoing feedback, mentoring, training and ensuring employees receive development opportunities
  • Collaborates with division partners to ensure product development project plans and resources are properly developed and maintained
  • Coordinates the Design Assurance resource loading for the franchise’s Design Quality Assurance Sustaining and NPD activities
  • Identifies opportunities for improvement of the Product Development Process and initiates activities to support the improvement process
  • Participates in the development of the new products and processes, issues resolutions and design reviews participation
  • Acts as an adviser to subordinates and may become actively involved, as required, to meet schedules and resolve problems
  • Participates on teams, projects and assignments, facilitating or leading teams as necessary
  • Provides guidance to test methods, equipment acquisition, sample plan definition, and validation development
  • Participates in technical documentation of the international submissions
  • Assures product and process adherence to applicable medical device and electrical safety standards
  • Participates in internal and external audits
  • Presents data to upper management related to departmental metrics and key project milestones

 

What we are looking for in you:


Minimum Qualifications: 

  • Bachelor's degree in engineering/technical discipline or equivalent
  • Minimum of 7 years of experience in quality and/or design assurance work experience in a regulated industry
  • Ability to travel up 15% (domestic and international)

 

Preferred Qualifications: 

  • Experience in the medical device industry
  • In depth familiarity with the FDA, ISO, MDD, EU MDR and the medical device industry quality requirements associated with product development, design controls, and product risk management
  • Previous BSC experience preferred 
  • Supervisory and performance management/coaching experience
  • Electrical or systems experience a plus

 

Requisition ID: 541454


Nearest Major Market: Boston

Job Segment: Quality Manager, Medical Device, QA, Quality Assurance, Surgery, Quality, Healthcare, Technology

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