Boston Scientific Sr Supplier QA Engineer 

United States, Minnesota 

340496194

Spencer Gregory Hale

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:

• Bachelor's 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

Maximum Salary: $ 156900

Compensation fornon-exempt (hourly), non-sales rolesmay also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation forexempt, non-sales rolesmay also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.

Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.