Medical Device Quality Assurance Leadership
hace 3 semanas
At Boston Scientific, we are committed to advancing science for life by transforming lives through innovative medical solutions. We seek a highly skilled Design Assurance Manager to lead our quality team in Heredia CR and play a key role in sustaining single-use devices for our Peripheral Interventions business.
Salary Range: $120,000 - $180,000 per year
Job Description
The successful candidate will be responsible for providing design assurance leadership for Single Use Devices and leading a team of skilled engineers. This includes ensuring product quality and compliance, applying design control and risk management principles, and partnering with cross-functional teams to achieve product sustainment within the Peripheral Intervention Division. Key responsibilities include:
- Leads quality team in sustaining activities to support commercial product monitoring on projects of major magnitude and scope.
- Key Quality voice of influence on projects.
- Leads quality team on functional deliverables and ensures technical excellence for product or technical development.
- Owning and driving deliverables related to Design Controls, Risk Management, Product Performance, Quality, and Compliance.
Required Skills and Qualifications
We require a minimum of a Bachelor's degree and 7 years of related work experience or an equivalent combination of education and work experience. The ideal candidate should have proven technical leadership and project management skills in medical device design, development, and commercialization, as well as strong communication and presentation skills. Additionally, they should have knowledge of Design Controls, Risk Management, NCEP/CAPA, Post-Market Surveillance, and FDA/ISO Medical Device Regulations. Experience with leading technical teams, familiarity with BSC products, and customer needs is preferred.
Benefits
Boston Scientific offers a comprehensive benefits package, including Life-Work Integration, Community, and Career Growth opportunities. As a global team, we strive to make a difference in people's lives around the world. Join us and find a career with meaningful purpose
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