Sr Quality Engineer

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:
Develops, establishes and maintains quality engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements.   Serves as a Quality representative to improve awareness, visibility, communication on quality initiatives to support departmental, functional, site, divisional and corporate quality goals and priorities.  Provides focused quality engineering support within new product development, operational, or system/services support.

 

Your responsibilities will include:

• Provides leadership role on championing departmental or cross-functional engineering initiatives.
• Provides project direction, coaching, and mentoring for engineering and technical team personnel.
• Proactively investigates, identifies, and implements best-in-class Quality Engineering practices.
• Mentor for technical guidance for identifying and resolving quality issues.
• Identifies and implements effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements.
• Leads in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements.
• Acts as an effective leader or team member in supporting quality disciplines, decisions, and practices.
• Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Assures the development and execution of streamlined business systems which effectively identify and resolve quality issues.

 

What we're looking for in you:
Required Qualifications

• Bachelor’s degree in Biomedical Engineering or related engineering discipline
• 5+ years of technical experience in the medical device or pharmaceutical industry
• Validation experience
• Knowledge of risk management concepts, proven track record of developing, implementing and execution
• Internal/External audit experience
• 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: 572879

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 a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-