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Quality Assurance Engineer III
2 months ago
Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance
At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we'll help you in advancing your skills and career. Here, you'll be supported in progressing - whatever your ambitions.
Design Quality Assurance Engineer III- Marlborough, MA
About the Role:
At Boston Scientific, the Design Quality Assurance Engineer III directly supports medical device product development from concept through commercialization. This individual will work with a high-performance cross-functional development team to ensure safety, quality and compliance of launched products while continuously improving their commercial value. Initially, this position supports the transition of the current commercial portfolio to meet European Union Medical Device Regulation (EUMDR) requirements. This position is part of the design site for the Endoscopy division and can support activities including but not limited to New Product Development, Sustaining and Life Cycle Management and Quality Systems initiatives as they relate to design and development.
Provides quality engineering support to operations, product development and sustaining projects for current products on the market. Develops, establishes, and maintains quality-engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements. Serves as a Quality representative to improve awareness, visibility, and communication on quality initiatives to support assigned departmental, functional, site, divisional and corporate quality goals, and priorities. Provides quality engineering support within technical development projects, new product development projects, sustaining existing product families, or system/services support.
This is a hybrid position based out of Marlborough, MA with the expectation to be in the office a minimum of three days per week.
Your Responsibilities Include:
- Identifies and implements effective risk management and process and design control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external quality and regulatory requirements. Specifically, in relation to achieving and continuity compliance to the EU MDR regulation.
- Creation and review of Risk Management documentation such as Hazard Analysis, Task Analysis, Design Failure Mode, and Effects Analysis (DFMEA) and Fault Tree Analysis (FTA). Understand and support linkage of field data and Risk Management
- Working knowledge of Design Controls. Provide quality and compliance input to project teams for project decisions and deliverables (i.e., Design Change Analysis, Design Inputs, Design Outputs, Test Methods, Design Reviews, Design V&V, Usability Testing, SW Validation, Process Validation and Labeling).
- Function as key team member to the EU MDR transition team in updating and bringing Design History Files to state-of-the-art readiness including risk management and Post Market Surveillance activities.
- Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues (i.e., 5 Whys analysis, Is-Is Not analysis, DMAIC problem solving methodologies).
- Provide quality guidance to assure country specific compliance.
- Champion compliance to company policies, work instructions and SOPs.
- Checks and provides support in the execution and investigation of CAPAs, NCEPs, Failure Mode Investigations, etc.
Required Qualifications:
- BS in Mechanical, Electrical, Biomedical Engineering, or related degree.
- 3+ years of Medical Device engineering experience with BS, 2+ years with MS.
- Detailed understanding and working knowledge of the FDA, ISO, EUMDR and the medical device industry quality requirements associated with product development, design controls, product risk management, and usability engineering.
- Ability to collaborate and work on a global team.
- Competent with use of Microsoft Office Suite
- Travel approximately
