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Job Overview
The Senior Quality Assurance Engineer specializing in Risk Management plays a pivotal role in orchestrating, planning, and executing risk management initiatives for products currently in the design and development phase, with a strong focus on Cyber Security. This position involves leading interdisciplinary teams throughout the product lifecycle to ensure that all essential risk management tasks are conducted in alignment with the established quality system.
Key Responsibilities
- Collaborate effectively with engineering, design, commercial, and product teams to identify all potential hazards associated with products, ensuring that risks are thoroughly assessed, controlled, and documented. Monitor the implementation, verification, and validation of risk controls for products under development.
- Ensure that product risk management documentation adequately addresses cyber-security risks as mandated by relevant standards.
- Strategically plan and execute risk management for projects, ensuring that processes are efficient and sufficiently detailed to support new product development.
- Conduct and document Risk Reviews to communicate the outcomes of the risk management process to cross-functional teams.
- Facilitate the harmonization of risk management strategies across various projects and their lifecycles by engaging with other Risk team members involved in different aspects of the risk management lifecycle.
- Review quality system outcomes to confirm compliance with applicable standards and the Quality Management System (QMS).
- Identify opportunities for continuous enhancement of the Risk Management Process.
Additional Responsibilities
- Provide ongoing training on standards and processes to other associates or functions as necessary.
- Support critical initiatives and planning efforts.
Qualifications
- Bachelor's degree in a relevant field.
- A minimum of 5 years of experience in risk management and cybersecurity.
- Experience in the medical device industry or other regulated sectors.
- Familiarity with ISO 13485 and ISO 14971 standards.
- Strong skills in cross-functional collaboration.
- Proven expertise in AAMI TIR57, IEC 80001, and related standards.
Preferred Qualifications
- Technical experience with automated dispensing systems.
- Experience with IEC 60601 and IEC 62304 standards.
Why Work with Us?
A career at BD means being part of a culture that values your insights and contributions, fostering an environment where you can bring your authentic self to work. We are committed to helping each other excel, doing what is right, holding one another accountable, and continuously learning and improving.
At BD, you will find a culture that encourages personal and professional growth, allowing you to contribute to making the world a healthier place.
