Quality Systems 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.

Advancing possibilities for a brighter tomorrow

We are seeking a Quality Systems Engineer II on a permanent basis to join our team.

Purpose:

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.

Key Responsibilities:

• Demonstrate a primary commitment to patient safety and product quality.
• Responsible for the implementation, co-ordination and continuous review and support of all site eCAPA activities.
• Has expertise in internal auditing techniques and is familiar with all regulatory requirements (e.g., FDA, ISO and other Regulations).
• Acts as an effective team member in supporting quality system disciplines, decisions, and practices.
• Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality system/compliance issues.
• Drives changes in procedures and standards to facilitate on going improvements and to maintain quality.
• Actively drives and supports continuous improvement initiatives.
• Provide support during preparation and execution of site external regulatory audits.
• Acts as a leader of quality within one’s own group, constantly promoting awareness of best industry practices, making appropriate decision on a daily basis.

Education & Experience:

• Level 8 qualification in Engineering or related technical/Quality discipline.
• 3+Years relevant work experience 

• Experience in the medical device industry.
• Working knowledge and understanding of FDA, ISO13485, and the medical device industry quality requirements associated with manufacturing and supplier controls.

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 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!

To search and apply for open positions, visit: https://bostonscientific.eightfold.ai/careers

At Boston Scientific, we recognise that nurturing a diverse and inclusive workplace helps us be more innovative. It is essential in advancing science for life and improving patient health. 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 is committed to providing reasonable accommodations for applicants and employees with a disability. Should you require a reasonable accommodation during the recruitment process, please email TalentAcquisitionIre@bsci.com