Quality System Analyst- Latam - based in Argentina

Additional Locations: Argentina-Buenos Aires

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.

Boston Scientific is a diverse company that is committed to empowering women, the LGBTQ+ community, and people with disabilities. We believe that diversity is a strength, and we are dedicated to creating an inclusive environment where all employees can thrive. We are proud to be an equal opportunity employer, and we welcome applications from all qualified candidates regardless of their background or identity.

** This position will be hired by an outsourcing 

Purpose statement:

The Quality System Engineer II 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.

Key responsibilities: 

• Responsible for the communication and documentation of 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.
• Documents non-conformances, evaluates impact, and makes recommendations for corrective actions.
• Communicates non-conformances to owners, managers, directors, and upper management.
• 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.
• Participates on CAPA and Continuous Improvement project teams as appropriate.
• Other duties as necessary or required by the department or organization.

What we’re looking for in you:

• Bachelor's degree and 3+ 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 organization.
• Understanding of quality system requirements as stated within 21 CFR Part 820 and ISO 13485
• Technical writing and documentation skills
• Strong communication, presentation, facilitation, and project management skills.
• Organizational skills with good attention to detail.
• Fluent in English language
• Good knowledge of Microsoft Excel
• Good working knowledge of SAP would be beneficial
• Willingness to travel internationally

Requisition ID: 572450

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!