Boston Scientific is seeking a Quality System Engineer III to serve as a Quality representative to improve awareness, visibility and communication on quality initiatives and objectives, and to support assigned departmental, functional, site, divisional and corporate quality goals and priorities. This role will support Quality initiatives, ensuring compliance to Medical Device regulations and BSC Quality System requirements with a continuous improvement mindset.
Requirements
- Understanding of quality system requirements as stated within 21 CFR Part 820 and ISO 13485
- Technical writing and documentation skills
- Project management skills
- Good knowledge of Microsoft Excel
- Good working knowledge of SAP and non-device software validation would be beneficial
Responsibilities
- Communicate and document internal and external compliance-related information including changes in regulations, new guidelines and guidance documents and other information from regulatory authorities
- Apply effective, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
- Assure the development and execution of streamlined business systems, which effectively identify and resolve quality issues
- Document and communicate non-conformances, evaluates impact, and makes recommendations for corrective actions
- Supports departmental, functional, divisional, and corporate quality goals and priorities
- Act as team member in supporting quality disciplines, decisions, and practices
- Builds quality into all aspects of work by maintaining compliance to all quality requirements
Other
- Bachelor's degree and 4+ years of experience in a medical device manufacturing, quality or regulatory/compliance environment
- Previous experience in Quality Systems or Country/Distribution QA or having experience in working in the Commercial/Supply Chain organisation
- Fluent in English language
- Strong communication, presentation, facilitation skills
- Organizational skills with good attention to detail
