Boston Scientific Supplier QA Engineer II 

United States, Minnesota, Arden Hills 

877944523

Spencer Gregory Hale

Your responsibilities will include:

• Assess suppliers for technical, quality and manufacturing capabilities.
• 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.
• Investigates field failures related to supplier materials. Develop corrective action plan where necessary.
• 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.
• Contributes to the completion of specific programs and projects. Failure to obtain results or erroneous decisions or recommendations would typically result in serious program delays and considerable expenditure of resources.
• 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.

What we're looking for in you:

Minimum qualifications:

• Bachelor's degree in engineering/technical field such as materials science, chemical or mechanical engineering and 3 years related experience or master’s degree and 2 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.
• Ability to communicate cross functionally, with suppliers, team members and leadership

Preferred Qualifications:

• Experience with or lead auditor certification to ISO13485, 9001, TS16949 standards
• Experience with auditing supplier quality systems

Among other requirements, Boston Scientific maintains specificprohibited substancetest requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to aprohibited substancetest as a requirement. The goal of theprohibited substancetesting is to increase workplace safety in compliance with the applicable law.