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QA Engineer II Job

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Date: Oct 2, 2021

Location: Marlborough, MA, US, 01752

Company: Boston Scientific

Additional Locations: US-MA-Marlborough; US-MN-Arden Hills; US-MN-Maple Grove

 

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.

 

QA Engineer II
 
About This Role:

 

This role provides support to the Global Post Market organization in a variety projects with a focus on Acquisitions, Divestitures, CAPA and GSM, and requires strong business process analysis and quality system documentation skills to drive and manage the implementation of Post Market projects. This role provides opportunity to further develop experience and expertise in the following areas supported by this team.  This individual must demonstrate strong organizational (work/time management) and technical writing skills with an adequate understanding of Post Market processes and requirements. Experience and training in Industrial Engineering and Agile methodology is preferred.

 

Your Responsibilities Include:

  • Supporting/leading Post Market projects by identifying, documenting, and tracking appropriate project deliverables,
  • Setting appropriate timelines that align with key project milestones,
  • Collaborating with cross-divisional/regional/functional representatives to gather required information,
  • Identifying opportunities for improvement and supporting Post Market projects/initiatives,
  • Supporting project teams and provides subject matter expertise regarding Post Market requirements and activities,
  • Identifying and ensuring training needs are addressed prior to integration or implementation of any new process,
  • Establishing and maintaining processes and quality records generated to address requirements,
  • Applying sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues, and
  • in all actions, demonstrating a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures. 


What We’re Looking for in You:

 

Minimum Qualifications

  • Bachelor’s Degree in the Engineering or Science field with 3-5 years of related experience or an equivalent combination of education and work experience
  • Comprehensive understanding of quality system requirements from US and International regulations and standards applicable to Medical Devices, including 21 CFR 803 & 820, ISO 13485:2016
  • Strong analytical skills and working knowledge of Trackwise, Windchill, eCAPA and/or SAS applications
  • Demonstrated quality system documentation skills, including quality records (e.g. complaints, investigations, vigilance reports), Project Tracking Plans, Complaint Management Plans, SOPs, WIs or templates
  • Strong communication skills (written and verbal), e.g. comfortable speaking and presenting to different levels of management and cross-functional stakeholders
  • Flexible and positive attitude; self-starting

 
Preferred Qualifications

  • Lean Business Process/DMAIC/Kaizen Experience/Process Mapping
  • NCEP/CAPA experience
  • Project Management experience
  • Experience with Post Market systems / processes (or related quality process, i.e., Design Assurance, Supplier Quality, Regulatory)
  • Experience with documenting GSM deliverables (e.g. validation documents, GSM Assessments, Small Project Documents)
  • Ability to work independently with minimal supervision

 

 

Requisition ID: 503557


Nearest Major Market: Boston

Job Segment: Medical, Engineer, CAPA, Developer, QA, Healthcare, Engineering, Management, Technology, Quality