Senior Quality Manager, CDx Services at Boston Scientific Corporation Malaysia

, , United States -

Full Time

Start Date

Immediate

Expiry Date

05 Mar, 26

Salary

0.0

Posted On

05 Dec, 25

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Management, Regulatory Compliance, Process Ownership, CAPA Management, People Leadership, Strategic Thinking, Collaboration, Communication, Interpersonal Skills, Change Leadership, Budget Management, Cross-Functional Initiatives, Stakeholder Influence, Diversity and Inclusion, Technical Knowledge, Operational Policies

Industry

Medical Equipment Manufacturing

Description

Lead, coach, and develop team to build expertise, accountability, and long-term talent capability within the organization. Fosters a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives. Create an entrepreneurial environment. Provides direction and guidance to exempt specialists and/or supervisory staff who exercise significant latitude and independence in their assignments. May supervise non-exempt employees. Keeps the organization's vision, values and objectives at the forefront of decision making and action. Demonstrates effective change leadership. Builds strategic partnerships to further departmental and organizational objectives. Develops and executes organizational and operational policies that affect one or more groups by utilizing technical/professional knowledge and skills. Monitors compliance with company policies and procedures (e.g. compliance with FDA, BSI, Medicare, EEO regulations, etc.). Make decisions regarding work processes or operational plans and schedules to achieve department objectives. Develop, monitor, and appropriately adjust the annual budget for department(s), as necessary. Provides appropriate level of cross-functional and customer-oriented communication regarding the status of department and quality system operation, as well as product performance. Influence and collaborate with a diverse stakeholder base to adapt processes, represent the voice of quality, and drive adoption of best practices. Build and sustain networks across the overall CDx business group to ensure aligned processes and consistent execution. Bachelor's degree in engineering, or related technical/science-based field. Minimum of 8 years of experience in Quality or Operations roles within a regulated industry (medical device, pharmaceutical, or related). Strong knowledge of Quality Systems and regulatory requirements (ex: FDA, EU MDR, ISO 13485). Demonstrated experience with process ownership, CAPA management, and compliance leadership. Proven track record of leading cross-functional initiatives and influencing stakeholders at peer group and 1-up level. Demonstrated experience in people leadership, including managing, coaching, and developing teams. Minimal travel required. Advanced degree (MS, MBA, or equivalent). Experience with complex systems within a regulated business. Knowledge of EKG arrhythmia and the adjudication of such. Strong strategic thinking capability with the ability to balance long-term vision with executional excellence. Experience supporting a wide range of employee groups. Ability to drive change in a matrixed organization. Willingness to drive and complete actions when situation arises. Excellent collaboration, communication, and interpersonal skills with the ability to work across locations.

Responsibilities

Lead and develop a team to enhance expertise and accountability while fostering a diverse workplace. Ensure compliance with regulatory standards and drive strategic partnerships to achieve departmental and organizational objectives.