Quality Engineer II

The Quality Engineer II will utilize quality-engineering methodologies, systems, and practices to support a manufacturing and distribution supply chain environment. This engineer will be assigned to support the Boston Scientific Quincy site supply chain interacting with third party logistic partners, supplier controls and general Distribution and manufacturing engineering controls. This engineer will serve as a key Quality representative to improve awareness, visibility, communication on quality initiatives to support departmental, functional, site, divisional and corporate quality goals and priorities.

Your responsibilities will include:

• Identify and implement effective process controls and systems to support the development, qualification, and on-going production and distribution of products to meet or exceed internal and external requirements.
• Provide direct third party logistic day-to-day supply chain support alongside supplier control support.
• Effectively contribute, evaluate, review and approve SOPs/Wis, project plans, risk management files and process verifications.
• Lead in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements.
• Acts as an effective team contributor in supporting quality disciplines, decisions, and practices.
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Engage in the development and execution of consistent and efficient quality processes to ensure compliance and support the business.
• Collaborate cross functionally with local and divisional team members on assigned projects to ensure quality compliance.
• 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.

Required qualifications:

• Bachelor's degree or higher in engineering, technology, life science, or related discipline
• Experience in supplier controls
• 2+ years working in the Medical Device industry (or similar field) in a role directly supporting supply chain, manufacturing or production environment
• Experience in Lean, Six Sigma, Process Improvement, Root Cause Analysis, Critical Thinking/Problem-solving skills
• Excellent interpersonal and relationship building skills
• Ability to travel up to 5%

Preferred qualifications:

• Experience with Supply Chain distribution
• Exposure to packaging and final pack requirements
• Proven ability to influence without authority
• Attention to detail