Boston Scientific
Sr. Supplier QA Engineer
Work mode: Hybrid Onsite Location(s): Arden Hills, MN, US, 55112 About the Role
The Senior Supplier Quality Engineer will play a key part in leading performance improvement of suppliers and increasing the suppliers capabilities to consistently meet Boston Scientifics 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 External Operations 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. Evaluate supplier changes for product and compliance impact. Responsible for supplier qualification, onboarding, and performance monitoring based on supplier risk. Assess and drive reactive as well as proactive supplier projects/investigations in collaboration with Supplier Engineering, Commercial Sourcing, and Design Assurance. Generate and review quality plans, agreements, product specifications, component qualifications, design verification/validations, and process validations. Plan and lead ISO 13458-focused audits of suppliers to assess compliance with regulatory and Boston Scientific requirements. Determine assessment outcomes and drive corrective actions/proactive preventative actions to closure. Evaluate and communicate quality issues to suppliers, applying sound, systematic problem-solving methodologies to identify, prioritize, and resolve quality issues. Review and approve supplier corrective action plans and effectiveness documentation. Develop solutions to complex problems of diverse scope and complexity where data analysis requires evaluation of identifiable factors. Exercise authority and judgment within generally defined practices and policies to select methods and techniques for obtaining solutions. Possess broad knowledge of various alternatives and their impact on the business unit. Plan and organize non-routine tasks with approval. Initiate or maintain work schedule and priorities. Plan and organize project assignments and maintain project schedules. Work under general direction regarding the progress of projects and special assignments. Independently determine and develop approaches to solutions. Interpret, execute and recommend modifications to company policies. Assist in establishing departmental policies and procedures. Work is reviewed upon completion for adequacy in meeting objectives. Establish and cultivate a wide range of business relationships to facilitate the completion of assignments. Interact with suppliers. Participate in determining goals and objectives for projects. May lead projects within the function or department and/or represent a specialized field in larger project teams. Influence middle management on business solutions. In all actions, demonstrate a primary commitment to patient safety and product quality by maintaining compliance with the Quality Policy and all other documented quality processes and procedures. Assure that appropriate resources (personnel, tools, etc.) are maintained to ensure Quality System compliance and adherence to the Quality Policy. Establish and promote a work environment that supports the Quality Policy and Quality System. Champion 100% compliance with company policies and SOPs. Identify and advise management on potential improvements to quality systems and processes in the company. Required Qualifications:
Bachelors degree in engineering/technical field such as Biomedical Engineering, 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 Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs.
Work mode: Hybrid Onsite Location(s): Arden Hills, MN, US, 55112 About the Role
The Senior Supplier Quality Engineer will play a key part in leading performance improvement of suppliers and increasing the suppliers capabilities to consistently meet Boston Scientifics 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 External Operations 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. Evaluate supplier changes for product and compliance impact. Responsible for supplier qualification, onboarding, and performance monitoring based on supplier risk. Assess and drive reactive as well as proactive supplier projects/investigations in collaboration with Supplier Engineering, Commercial Sourcing, and Design Assurance. Generate and review quality plans, agreements, product specifications, component qualifications, design verification/validations, and process validations. Plan and lead ISO 13458-focused audits of suppliers to assess compliance with regulatory and Boston Scientific requirements. Determine assessment outcomes and drive corrective actions/proactive preventative actions to closure. Evaluate and communicate quality issues to suppliers, applying sound, systematic problem-solving methodologies to identify, prioritize, and resolve quality issues. Review and approve supplier corrective action plans and effectiveness documentation. Develop solutions to complex problems of diverse scope and complexity where data analysis requires evaluation of identifiable factors. Exercise authority and judgment within generally defined practices and policies to select methods and techniques for obtaining solutions. Possess broad knowledge of various alternatives and their impact on the business unit. Plan and organize non-routine tasks with approval. Initiate or maintain work schedule and priorities. Plan and organize project assignments and maintain project schedules. Work under general direction regarding the progress of projects and special assignments. Independently determine and develop approaches to solutions. Interpret, execute and recommend modifications to company policies. Assist in establishing departmental policies and procedures. Work is reviewed upon completion for adequacy in meeting objectives. Establish and cultivate a wide range of business relationships to facilitate the completion of assignments. Interact with suppliers. Participate in determining goals and objectives for projects. May lead projects within the function or department and/or represent a specialized field in larger project teams. Influence middle management on business solutions. In all actions, demonstrate a primary commitment to patient safety and product quality by maintaining compliance with the Quality Policy and all other documented quality processes and procedures. Assure that appropriate resources (personnel, tools, etc.) are maintained to ensure Quality System compliance and adherence to the Quality Policy. Establish and promote a work environment that supports the Quality Policy and Quality System. Champion 100% compliance with company policies and SOPs. Identify and advise management on potential improvements to quality systems and processes in the company. Required Qualifications:
Bachelors degree in engineering/technical field such as Biomedical Engineering, 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 Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs.