Engineer, Sr Quality

Hiring Manager: Ritesh Deliwala
Recruiter: Spencer Gregory Hale

Senior Service Quality Engineer 

About the role:
This is a great time to join Boston Scientific and make a difference in patients' lives, every day.  We are 50,000 colleagues strong, with an impressive portfolio of 13,000 products.   Boston Scientific manufactures and services medical electrical equipment (MEE) devices to improve the quality of patient care. MEE utilizes various technologies including but not limited to laser, radio frequency, gas and liquid pressure and flow dynamics, and ultrasound. The Global Technical Equipment Service organization provides support directly to the customer in relation to device installation, field repair, preventive maintenance, and periodic safety evaluations. This position supports all divisions within Boston Scientific creating a unique opportunity to work with peers across the organization within Design, Manufacturing, Post Market, Sales, Regional or Country teams, Distribution, and Global Quality System Stewards.
 
Your responsibilities:
The Senior Service Quality Engineer provides quality (MEE) support for the Global Technical Service organization. Supports evaluation of product service documentation in relation to design quality system and regional requirements working in partnership with the service development engineers. Develops solutions to a variety of problems of diverse scope and complexity. Exercises authority and judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.  Utilizes broad knowledge of the Quality System to assess and ensure changes occurring within service create a positive impact on the quality system and business organization. Evaluates the adequacy and compliance of systems, operations, and practices against regulations as well as company documentation. 

• Develop and implement quality plans, to support service integration activities. Analyze and document risk mitigations to support integration project timelines.  
• Investigate and execute Correction and Corrective Actions to improve the global service performance
• Review global product service plans, risk documents, change analysis, work instructions, and related hard and digital checklists for compliance to design specification and regulation requirements
• Drive systemic process improvements with a focus on a global organization
• Identify and drive Value Improvement Projects

What we are looking for:
Minimal requirements: 

• Bachelor’s degree in a technical field
• 5+ years of related work experience including relevant experience in the Medical Device industry
• Excellent written and verbal communication skills, with the ability to work with partners across the company

 
Preferred qualifications:

• Bachelor’s or higher degree in engineering 
• Working knowledge of IEC13485,60601,62353 and 21CFR820 regulations
• Experience working with medical electrical equipment
• ASQ Certification in Six-Sigma Green Belt and/or Quality disciplines

Requisition ID: 559177