Quality Sr, Manager at Boston Scientific Corporation Malaysia

Heredia, , Costa Rica -

Full Time

Start Date

Immediate

Expiry Date

06 Feb, 26

Salary

0.0

Posted On

08 Nov, 25

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Management, Design Controls, Risk Management, Product Performance, Compliance, Verification and Validation, Failure Investigations, Technical Leadership, Project Management, Medical Device Regulations, Cross-Functional Collaboration, Continuous Improvement, Audit Experience, Customer Insight, Team Development, Communication Skills

Industry

Medical Equipment Manufacturing

Description

Leads quality team on product development 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. Owns and drives deliverables related to Design Controls, Risk Management, Product Performance, Quality, and Compliance, key partner in all department goals and objectives. Including leading V&V activities and failure investigations. Partners with Sustaining functional partners to support commercial product monitoring and all related product sustainment activities. Develops and implements quality strategies; seeks innovative approaches to attaining quality goals, including continuous improvement and VIP. Hire, develop, and coach direct and indirect reports to provide technical leadership and support of multiple projects, and drive best practices throughout the organization. Foster a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives. Determines appropriate staff levels and schedules. Works with key partners to understand priorities and plans resource allocation accordingly. Maintains and enhances cross-functional team relationships. Provides significant guidance regarding technical strategies and approaches; works cross-functionally in identifying and resolving technical issues. Monitor and ensure compliance with company policies and procedures (e.g. federal/country and regulatory requirements). Directly interfaces with internal and external audit activities. Minimum of a Bachelor's degree Minimum of 8 years of related work experience or an equivalent combination of education and work experience. Minimum of 4 years of Leadership experience Proven technical leadership and project management skills in medical device design, development, and commercialization Software and Electronic Medical Equipment (EME) experience Proven independent critical thinker, strong communication skills, strong presentation skills, and ability to build effective cross-functional relationships Ability to interface with customers to gather insight and get organizational buy-in on key design inputs Audit experience Knowledge of Design Controls, Risk Management, NCEP/CAPA, Post-Market Surveillance, and FDA/ISO Medical Device Regulations Medical Device or regulated industry experience Please submit Resume in English B.S. in an engineering discipline Advanced degree in technical field or business. Experience leading technical teams. Experience with Design Controls, Risk Management, NCEP/CAPA, Post-Market Surveillance, and FDA/ISO Medical Device Regulations. Familiarity with BSC products and customer needs

Responsibilities

Leads the quality team on product development projects, ensuring technical excellence and compliance with quality standards. Partners with various functional teams to support product monitoring and sustainment activities.