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Senior Quality Assurance Specialist
2 months ago
Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance
At Boston Scientific, we provide an environment where you can leverage your full potential by collaborating with a diverse and high-achieving workforce, addressing critical challenges in the healthcare sector. With access to cutting-edge tools, resources, and training, we are committed to helping you enhance your skills and advance your career. Here, you will find support in your professional growth, no matter your aspirations.
Role Overview:
The Senior Quality Assurance Engineer plays a pivotal role in supporting the development of medical devices from initial concept to market launch. This position involves collaboration with a high-performing, cross-functional team to ensure that products meet safety, quality, and compliance standards while continuously enhancing their market value. Initially, this role will focus on transitioning existing products to comply with European Union Medical Device Regulation (EUMDR) requirements. This position is part of the design team for the Endoscopy division and will engage in activities related to New Product Development, Sustaining and Life Cycle Management, and Quality Systems initiatives associated with design and development.
The engineer will provide quality assurance support to operations, product development, and sustaining projects for currently marketed products. Responsibilities include developing, establishing, and maintaining quality-engineering methodologies, systems, and practices that align with Boston Scientific, customer, and regulatory standards. The role also involves serving as a quality representative to enhance awareness, visibility, and communication regarding quality initiatives to support departmental, functional, site, divisional, and corporate quality objectives.
Key Responsibilities:
- Identify and implement effective risk management and process control systems to support the development, qualification, and ongoing manufacturing of products that meet or exceed internal and external quality and regulatory standards, particularly concerning EU MDR compliance.
- Create and review Risk Management documentation, including Hazard Analysis, Task Analysis, Design Failure Mode and Effects Analysis (DFMEA), and Fault Tree Analysis (FTA). Facilitate the connection between field data and Risk Management.
- Possess a solid understanding of Design Controls and provide quality and compliance insights to project teams for project decisions and deliverables (e.g., Design Change Analysis, Design Inputs, Design Outputs, Test Methods, Design Reviews, Design Verification and Validation, Usability Testing, Software Validation, Process Validation, and Labeling).
- Act as a key team member in the EU MDR transition team, updating and preparing Design History Files for state-of-the-art readiness, including risk management and Post Market Surveillance activities.
- Utilize systematic problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues (e.g., 5 Whys analysis, Is-Is Not analysis, DMAIC problem-solving methodologies).
- Provide quality guidance to ensure compliance with country-specific regulations.
- Champion adherence to company policies, work instructions, and Standard Operating Procedures (SOPs).
- Support the execution and investigation of Corrective and Preventive Actions (CAPAs), Non-Conformance Event Procedures (NCEPs), and Failure Mode Investigations.
Required:
- Bachelor's degree in Mechanical, Electrical, Biomedical Engineering, or a related field.
- 3+ years of experience in Medical Device engineering with a Bachelor's degree, or 2+ years with a Master's degree.
- In-depth understanding and practical knowledge of FDA, ISO, EUMDR, and the quality requirements in the medical device industry related to product development, design controls, product risk management, and usability engineering.
- Ability to collaborate effectively within a global team.
- Proficient in Microsoft Office Suite.
- Willingness to travel approximately
