Design Quality Assurance Engineer

Recruiter: Spencer Gregory Hale

Design Quality Assurance Engineer – Sustaining, Marlborough, MA  

Full Time - Hybrid  

 
About the role: 

Entry level position that provides quality engineering support for Infection Prevention (IP) products manufactured in Alpharetta, GA / John’s Creek, GA. The sustaining role develops, establishes, and maintains quality-engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements for products they will support. In the sustaining role, the engineer will 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 for selected products.  

Responsibilities include: 

DQA – Sustaining Engineering  

• Support collection and analysis of key quality trending information and data for specific products.   

• Identify and support effective controls for manufacturing and assembly of products. 

• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.  

• Develop understanding of Design Controls, Risk Management, and Usability for Medical Devices.  

• Provide quality and compliance input to project teams. 

• Support internal and external regulatory audits as required.  

• Provide quality and compliance input for Post Market product sustaining activities, such as design changes, supplier auditing and surveillance, design concessions, product CE marking and safety certification, customer complaint investigations, NCEPs, CAPAs, and Field Signals. 

Qualifications 

• Minimum of a BS in Life Science, preferably Mechanical Engineering or Biomedical Engineering.  

• Strong communication and presentation skills. 

• Competent with use of Microsoft Office Suite, Minitab Statistical Analysis software (or equivalent). 

• Ability to collaborate and work on a global team. 

• Position located in Marlborough, MA. 

• Hybrid, on-site a minimum of three days a week. 

Requisition ID: 598379

The anticipated annualized base amount or range for this full time position will be $ to $, plus variable compensation governed by Sales Incentive Compensation Plan (which includes certain annual non-discretionary incentives based on predetermined objectives) as well as the value of core and optional benefits offered at BSC, which can be reviewed at www.bscbenefitsconnect.com. Actual compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, and other relevant business or organizational needs.

For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions.  This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement.  The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.