Quality Engineer II

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.

Job Purpose:

The Quality Engineer will serve as a key Quality representative within the Galway Magellan Go Live readiness Program. You will ensure Magellan solutions meet Quality System requirements, Galway requirements, support testing and deployment activities, and drive quality-focused process improvements. 
 
A critical requirement for this position is the ability to understand existing SAP functionality in ECC and work towards understanding the new functionality in S4 to become a super user.
 
This role offers the opportunity to work on a project for a site SAP rollout involving planning, stakeholder engagement and execution with cross functional site and global Magellan personnel.

Key Responsibilities:

• Demonstrate strong commitment to the Quality Policy and compliance with 21 CFR Part 820, ISO 13485, and BSC Quality System requirements. 

• Build quality into all aspects of work and support compliant solution design, site activities for readiness.  

• Conduct business, quality and process impact assessments and execute readiness in conjunction with site cross functional teams and Magellan business support 

• Apply effective problem-solving methodologies to resolve quality issues. 

Business Readiness Support for site Magellan implementation

• Understand quality-related business requirements and translate info to Magellan functional reps to ensure requirements are understood.  
• Work with business areas through the duration of site readiness ensuring business requirements are understood, Magellan solution is appropriate and business readiness (training, business, quality  and process changes) is appropriate 
• Partner with Magellan business quality reps to ensure quality requirements are understood and implemented. 

• Facilitate workshops to evaluate current-state and future-state workflows if required
• Recommend quality process improvements and system enhancements. 

Solution Delivery & Testing 

• Work in conjunction with Business Magellan team to develop test plans, complete  test execution and work through testing results with Magellan teams for new S4 functionality.
• Work in conjunction with Business Magellan team to  Develop test plans for business readiness for SAP functionality already implemented under previous implementations.  

Stakeholder Collaboration & Communication 

• Act as liaison between Galway site business teams, Galway site Magellan teams  and global quality Magellan teams. 

• Communicate program/site risks, issues, and decisions clearly to Galway team and leadership if required . 

• Provide coaching and SME support to business Quality Engineers and Technicians. 

• Support CAPA, Lean, and continuous improvement initiatives. 

Audit & Quality Systems Support 

• Support audit readiness and document non-conformances if applicable. 

• Recommend appropriate corrective and preventive actions. 

• Contribute to development of streamlined quality business systems. 

Education & Experience:

• Hons bachelor’s degree in Engineering, Science, or related field. 

• 3+ years of Quality Engineering or Quality Systems experience in a regulated environment. 

• Strong SAP ECC knowledge will be extremely valuable for this role as it will help to be able to translate from ECC to S4

• Strong understanding of ISO 13485 and 21 CFR 820. 

• Experience supporting process or system transformation initiatives. 

• Excellent communication, documentation, and stakeholder management skills. 

Preferred Qualifications 

• Systems  and process thinker with strong analytical skills. 

• Comfortable operating in ambiguity with ability to bring clarity. 

• Strong relationship builder and collaborator. 

• High accountability, professionalism, and attention to detail. 

• Able to work effectively across functions and with global teams. 

• Strong analytical and technical writing skills. 

This is hybrid role – Min 3 days per week onsite

Requisition ID: 624897

Boston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 45 years, we advance science for life by providing a broad range of high-performance solutions that address unmet patient needs and reduce the cost of healthcare. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions. Learn more at www.bostonscientific.com and follow us on LinkedIn.