Boston Scientific is looking for a Quality Engineer II to support its manufacturing and distribution supply chain, focusing on improving quality initiatives and ensuring compliance with internal and external requirements.
Requirements
- 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
- Experience with Supply Chain distribution
- Exposure to packaging and final pack requirements
Responsibilities
- 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.
- 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
Other
- Bachelor’s degree or higher in engineering, technology, life science, or related discipline
- Excellent interpersonal and relationship building skills
- Ability to travel up to 5%
- Proven ability to influence without authority
- Attention to detail
