Senior Quality Assurance Engineer
2 weeks ago
Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance
At Boston Scientific, we provide a platform for you to leverage your full potential by collaborating with a diverse and high-achieving workforce, addressing some of the most significant challenges in the healthcare sector. With access to cutting-edge tools, resources, and training, we are committed to fostering your professional growth and career advancement. Here, you will find support in your journey, regardless of your aspirations.
Position Overview:
The Senior Quality Assurance Engineer plays a pivotal role in the development of medical devices, guiding projects from initial concept to market launch. This role involves collaboration with a dynamic cross-functional team to ensure that all products meet the highest standards of safety, quality, and regulatory compliance while enhancing their market value. This position is essential in transitioning our existing product line to comply with European Union Medical Device Regulation (EUMDR) standards. As part of the design site for the Endoscopy division, responsibilities may include New Product Development, Sustaining and Life Cycle Management, and Quality Systems initiatives related to design and development.
The role includes providing quality engineering support to operations, product development, and ongoing projects for existing products. You will develop, implement, and maintain quality engineering methodologies, systems, and practices that align with Boston Scientific, customer, and regulatory standards. Acting as a quality representative, you will 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 design control systems to support product development, qualification, and ongoing manufacturing, ensuring compliance with internal and external quality and regulatory standards, particularly concerning EU MDR.
- Develop and review Risk Management documentation, including Hazard Analysis, Task Analysis, Design Failure Mode and Effects Analysis (DFMEA), and Fault Tree Analysis (FTA), while understanding the connection between field data and Risk Management.
- Possess a solid understanding of Design Controls, providing quality and compliance insights to project teams for critical project deliverables.
- Act as a key contributor to the EU MDR transition team, updating Design History Files to meet current standards, including risk management and Post Market Surveillance activities.
- Utilize systematic problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues effectively.
- Offer quality guidance to ensure compliance with country-specific regulations.
- Promote 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.
- A minimum of 3 years of experience in Medical Device engineering with a Bachelor's degree, or 2 years with a Master's degree.
- In-depth knowledge of FDA, ISO, EUMDR, and the quality requirements in the medical device industry related to product development, design controls, risk management, and usability engineering.
- Ability to work collaboratively within a global team.
- Proficiency in Microsoft Office Suite.
- Willingness to travel approximately
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