Supplier Quality Engineer III

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 Supplier Quality Engineer P3 on a basis to join our team.

Job Purpose:

The External Operations organization at Boston Scientific is a global team that oversees a diverse network of suppliers which manufacture finished devices for BSC distribution. The External Operations Supplier Quality Management group manages sustaining activities for externally manufactured finished goods in the BSC Quality System. In this role you will be working with PI divisional products with BSC cross-functional partners and suppliers to resolve quality issues and will play a key part in leading performance improvement of suppliers and increasing the supplier’s capabilities to consistently meet Boston Scientific’s requirements.

It will also provide the opportunity to be involved in supplier related projects across the global supplier quality management network in BSC. The role will require an element of travel as part of supporting and working with our suppliers.

Key Responsibilities:

• Responsible for quality performance of Sourced Finished Medical Device manufacturers (OEM and Contract Manufacturers)
• Evaluates and communicates quality issues to suppliers and applies sound, systematic problem-solving methodologies in identifying, risk assessing, prioritizing, and resolving quality issues.
• Investigates and solves non-conformances due to incoming inspection at BSC Distribution Centers
• Supports investigation of material Quality issues/ complaints as they arise and ensures that adequate Corrective Actions are identified, implemented and controlled by Suppliers
• Reviews and approves supplier corrective action plans and verification of effectiveness documentation through SCAR ownership
• Plans and leads supplier assessment to assess compliance with regulatory standards and Boston Scientific requirements.
• Technical Team Member partnering with Supplier Engineering and Commercial Sourcing for multiple aspects of Supplier Management supporting objectives of the team in terms of Quality, Cost and Service including Supplier originated changes, design and labelling changes.

• Supports sustaining quality issues, process change impacts, and design change implementations for suppliers within their Quality system, and in the BSC Quality System.
• Team member of New Product Development (NPD) projects with responsibilities for execution of applicable SFMD Plan deliverables and collaboration with cross-functional new product development teams to onboard finished medical device suppliers.

Education & Experience:

• Level 8 Degree in an Engineering or Technical Discipline
• 4+ years of related work experience in the regulated industry including demonstrated understanding of QSR and ISO standard requirements for Material/Purchasing Controls, Product Realization, Validation and CAPA.
• Ability to work independently; organized and self-driven.
• A strong communicator (written and verbal) who can effectively organize, present and explains data/ information with all internal & external stakeholders.
• Competency in Microsoft software systems e.g. MS Excel, PowerPoint, Power BI and in QMS software systems (CAPA, SCAR etc)
• Domestic and international travel up to 25%.

Preferred Qualifications:

• Prior experience within a quality function, preferably supplier quality.
• Knowledge of Medical Device regulations, specifically Material Controls Quality System requirements.
• Lead Assessor ISO13485 certification preferred.
• Familiarity with Drug coated products advantageous

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.

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