Quality System Engineer III

 

Additional Location(s): Argentina-Buenos Aires; Ireland-Cork; Ireland-Galway; Netherlands-Kerkrade; US-MA-Marlborough

 

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 System Engineer III will serve as a Quality representative to improve awareness, visibility and communication on quality initiatives and objectives, and will support assigned departmental, functional, site, divisional and corporate quality goals and priorities. Specifically, this role will support Quality initiatives, ensuring compliance to Medical Device regulations and BSC Quality System requirements with a continuous improvement mindset. 

 

Please note this is a hybrid position (in office minimum three days per week) ideally in Buenos Aires, Argentina, with the flexibility to be located in Marlborough, MA, Galway or Cork, Ireland, Kerkrade, Netherlands or other BSC site.  You will have the opportunity to discuss your preferred working location with your Talent Acquisition Specialist.

 

This is a Defined Term role for 12 months.

 

Boston Scientific will not offer sponsorship or take over sponsorship of an employment VISA for this position at this time.

 

Your responsibilities will include:

• Communicate and document internal and external compliance-related information including changes in regulations, new guidelines and guidance documents and other information from regulatory authorities
• Apply effective, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
• Assure the development and execution of streamlined business systems, which effectively identify and resolve quality issues
• Document and communicate non-conformances, evaluates impact, and makes recommendations for corrective actions
• Supports departmental, functional, divisional, and corporate quality goals and priorities
• Act as team member in supporting quality disciplines, decisions, and practices
• Builds quality into all aspects of work by maintaining compliance to all quality requirements
• Participate in CAPA and Continuous Improvement project teams as appropriate
• Other duties as necessary or required by the department or organization

 

Required qualifications: 

• Bachelor's degree and 4+ years of experience in a medical device manufacturing, quality or regulatory/compliance environment
• Previous experience in Quality Systems or Country/Distribution QA or having experience in working in the Commercial/Supply Chain organisation
• Understanding of quality system requirements as stated within 21 CFR Part 820 and ISO 13485
• Technical writing and documentation skills
• Project management skills
• Fluent in English language

 

Preferred qualifications:

• Good knowledge of Microsoft Excel
• Strong communication, presentation, facilitation skills
• Organizational skills with good attention to detail
• Good working knowledge of SAP and non-device software validation would be beneficial

 

 

#LI-Hybrid

 

 

 

Requisition ID: 611966 

Minimum Salary: $ 79700 

Maximum Salary: $ 151400 

 

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see www.bscbenefitsconnect.com--will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commens