Senior Supplier Quality Engineer

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 Senior Supplier Quality Engineer will play a key part in leading performance improvement of suppliers and increasing the supplier’s capabilities to consistently meet Boston Scientific’s requirements. Additionally, the Supplier Quality Engineer will support global sourcing, supplier manufacturing operations, and global quality systems by participating in global communities of practice and value improvement projects. The SFMD Supplier Quality Engineering team is looking for high energy, driven, passionate people, looking to not just change jobs, but start an amazing career!

Your responsibilities will include:

• Assess suppliers for technical, quality and manufacturing capabilities. Assess supplier changes for product and compliance impact.
• Responsible for supplier qualification, onboarding and performance monitoring based on supplier risk. Assess & drive reactive as well as proactive supplier project(s)/investigations partnering with Supplier Engineering, Commercial Sourcing, Design Assurance.
• Generate and review quality plans, agreements, product specifications, component qualifications, design verification/validations, and process validations.
• Plans and leads ISO 13485 focused audits of suppliers to assess compliance with regulatory and Boston Scientific requirements, including determining assessment outcomes and driving corrective actions/proactive preventative actions to closure.
• Evaluates and communicates quality issues to suppliers and applies sound, systematic problem-solving methodologies in identifying, prioritizing, and resolving quality issues. Reviews and approves supplier corrective action plans and verification of effectiveness documentation.
• Develops solutions to a variety of complex problems of diverse scope and complexity where analysis of data requires evaluation of identifiable factors. Exercises authority and judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Has a broad knowledge of a variety of alternatives and their impact on the business unit.
• Plans and organizes non-routine tasks with approval. Initiates or maintains work schedule and priorities. Plans and organizes project assignments and maintains project schedules.
• Works under general direction regarding the direction and progress of projects and special assignments. Independently determines and develops approach to solutions. Interprets, executes, and recommends modifications to company policies. Assists in establishing departmental policies and procedures. Work is reviewed upon completion for adequacy in meeting objectives.
• Establishes and cultivates a wide range of business relationships to facilitate completion of assignments. Interacts with suppliers. Participates in determining goals and objectives for projects. May lead projects within the function or department and/or represents a specialized field in larger project teams. Influences middle management on business solutions.
• In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures. Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the Quality Policy. Establishes and promotes a work environment that supports the Quality Policy and Quality System.
• Champions 100% compliance to company policies and SOPs. Identifies and advises management on potential improvements to quality systems and processes in the company.

Required qualifications:

• Bachelor's degree in engineering/technical field such as materials science, chemical or mechanical engineering and 5 years related experience.
• Experience with problem solving quality tools and CAPA.
• Experience in working with mechanical or electrical suppliers.
• Domestic and international travel up to 10%.
• Experience with technical documentation.
• Experience in process validation, design controls, risk management, and CAPA.

Preferred qualifications:

• Ability to communicate & influence cross functionally, with suppliers, team members, and leadership.
• Articulate communicator: adept at messaging and appropriately scaling information to the intended audience.
• Ability to work independently; organized and self-driven.
• Ability to rapidly learn and use new software applications (e.g., PLM, ERP).
• Leadership experience on a materials or service commodity team.
• Lead auditor of quality systems experience (ISO 13485 or similar).
• Experience with auditing supplier quality systems.
• ASQ certification (CQE, CBA, SSGB, SSBB) strongly desired.
• 7 years of related experience.

Requisition ID: 590975