Quality Systems 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 Systems Engineer II will utilize quality-engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements.  They will serve as a Quality representative to improve awareness, visibility, and communication on quality assurance initiatives to support assigned departmental, functional, site, divisional and corporate quality goals and priorities.  

 

Work Mode: Hybrid: minimum 2 days onsite (long-term); 2-5 days onsite during first month for onboarding
 

Your responsibilities will include:

• Act as a technical resource within the facility for review, approval and resolution of non-conformities within the facility.
• Lead and/or support continuous improvement projects, CAPA and LEAN initiatives. 
• Site champion for elements of the Quality System such as Management Review, Audit Readiness, Readiness Review and Other Quality Assurance projects.
• Provide technical support and leadership within the Quality Assurance and Quality Systems organization to support the Quality Policy and Quality System.
• Lead functional teams in developing solutions for quality related issues and seeking new opportunities for continuous improvement. Serve as Quality representation on project teams by providing guidance for maintaining compliance to regulatory and corporate requirements
• Review and approve PFMEAs for changes to existing and new processes from a quality perspective
• Lead and manage projects associated with site quality initiatives to assure that the distribution center’s interests are accurately and objectively represented from a quality perspective
• Implement use of quality assurance tools both internally and externally with the goal of improving control or addressing gaps to manufacturing and distribution processes and to eliminate non-value added activities.

 

Required qualifications:

• Bachelor’s degree or higher in engineering, technology, life science, or related discipline
• Minimum 2 years working in the Medical Device industry (or similar field), including nonconformance and CAPA review/approval
• Experience in Lean, Six Sigma, Process Improvement, Root Cause Analysis, Critical Thinking/Problem-solving skills
• Excellent interpersonal and relationship building skills

 

Preferred qualifications:

• Internal and/or external auditing experience
• Experience with supply chain distribution
  
  
   

Requisition ID: 575400

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-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!

 

At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. Boston Scientific is proud to be an equal opportunity and affirmative action employer.

 

Boston Scientific maintains a prohibited substance free workplace. Pursuant to Va. Code § 2.2-4312 (2000), Boston Scientific is providing notification that the unlawful manufacture, sale, distribution, dispensation, possession, or use of a controlled substance or marijuana is prohibited in the workplace and that violations wil