Design Assurance Manager
hace 15 horas
At Boston Scientific, we're passionate about creating innovative medical solutions that improve patient lives. As a Design Assurance Manager, you'll play a key role in ensuring our products meet the highest quality and regulatory standards.
Key Responsibilities:
- Lead quality teams in sustaining activities for commercial products, ensuring technical excellence and compliance with regulatory requirements.
- Develop and implement quality strategies, seeking innovative approaches to attaining quality goals and driving continuous improvement.
- Partner with cross-functional teams, including Research & Development, Regulatory, and Manufacturing Engineering, to achieve product sustainment within the Peripheral Intervention Division.
- Ensure compliance with company policies and procedures, as well as federal and country-specific regulatory requirements.
Requirements:
- Minimum of a Bachelor's degree.
- Minimum of 7 years of related work experience or an equivalent combination of education and work experience.
- Proven technical leadership and project management skills in medical device design, development, and commercialization.
- Knowledge of Design Controls, Risk Management, NCEP/CAPA, Post-Market Surveillance, and FDA/ISO Medical Device Regulations.
Preferred Qualifications:
- Bachelor's degree in an engineering discipline.
- Advanced degree in a technical field or business.
- Experience leading technical teams.
- Familiarity with Boston Scientific products and customer needs.
About Boston Scientific:
We're a global leader in medical science, committed to solving the challenges that matter most. Our mission is to advance science for life, transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate.
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