Quality Engineer II

Additional Location(s):  N/A

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.

 

 

About the role:

The Quality Engineer II serves as a quality representative who improves awareness, visibility and the communication of quality initiatives in support of functional, departmental, site, divisional and corporate quality goals and priorities.  This role is responsible for providing quality-based input to support manufacturing, operations and distribution activities, while leveraging extensive technical knowledge and experience across multiple product and production platforms.  The incumbent will develop, establish and maintain quality engineering methodologies, systems and practices to meet company, customer and regulatory requirements.    
 

Your responsibilities will include:

• Supporting specific production areas in achieving required quality standards; provide guidance to quality inspectors and technicians as needed 
• Leading and supporting cross-functional teams in identifying root causes and implementing corrective and preventative actions (CAPA) to control and reduce manufacturing process defects (scrap, nonconforming material, customer complaints); may be responsible for creating risk analyses and FMEAs
• Initiating and leading nonconforming events and CAPA projects; support internal and external regulatory audits
• Collecting and analyzing process defect data to support product and process improvement efforts; apply problem-solving methodologies to identify, prioritize, communicate and resolve quality issues
• Gathering and analyzing quality metric data to enhance sustaining product design and new product development; support site and divisional projects to ensure product introductions, processes and related changes meet regulatory requirements
• Assessing design and process changes to determine the impact on patient care and compliance to quality system requirements; own risk management documentation for assigned processes
• Leading continuous improvement projects and identifying best practices 

 
Required Qualifications:

• Bachelor’s degree in Biomedical Engineering or related discipline
• 3+ years of technical experience in the medical device or pharmaceutical industry
• Working knowledge of FDA QSR (21 CFR Part 820) and ISO 13485 with ability to understand other medical device regulations and standards
• Experience with nonconforming material, CAPA methodologies and related systems
• Experience working in cross-functional teams and driving projects to completion
   

Preferred Qualifications:

• Certified Six Sigma Green Belt (CSSGB)
• ASQ Certified Quality Engineer (CQE) or Biomedical Auditor (CBA)
• Project management experience with strong presentation and facilitation skills
• Working knowledge of analytical techniques and statistical analysis
• Proficient with Microsoft Office Suite and Minitab Statistical Analysis software (or equivalent)
• Ability to work independently and collaborate with cross-functional teams to complete projects 
• Strong interpersonal skills, with ability to communicate effectively with individuals on all levels
• Strong critical thinking and analytical skills: process and results-oriented
• Detail oriented with strong organizational skills; ability to multi-task and prioritize competing responsibilities effectively

 

 

Requisition ID: 576751

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

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.

 

So, choosing