Senior Quality Director at Boston Scientific Corporation Malaysia

Carlsbad, California, United States -

Full Time

Start Date

Immediate

Expiry Date

06 Jan, 26

Salary

0.0

Posted On

08 Oct, 25

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Engineering, Leadership, Collaboration, Change Leadership, Strategic Partnerships, Policy Development, Compliance Monitoring, Regulatory Compliance, Post-Market Surveillance, Vigilance Reporting, Inclusive Leadership, Influencing, Adaptability, Innovation, Execution, Professionalism

Industry

Medical Equipment Manufacturing

Description

Recruiting, coaching and developing organizational talent. Engaging with cross-functional partners and acquired teams/team members to enable collaborative solutions that result in broad wins. Fostering a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives. Creating an entrepreneurial environment. Providing direction and guidance to team members so they achieve individual, project and team goals. Keeping the organization's vision and values at the forefront of decision making and action. Demonstrating effective change leadership. Building strategic partnerships to further departmental and organizational objectives. Developing and executing organizational and operational policies that affect one or more groups by utilizing technical/professional knowledge and skills. Monitoring compliance with policies and procedures (e.g. compliance with FDA, BSI, EEO regulations, etc.). Making decisions regarding work processes or operational plans and schedules in order to achieve objectives. May serve as Quality System Management PRRC (Person Responsible for Regulatory Compliance) Representative (Article 15 of the Medical Device Regulation 2017/745), ensuring that conformity of devices are appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released. (Article 15a). Ensures that post-market surveillance obligations are complied with Article 10(10). (Article 15c) and that vigilance reporting obligations referred to in Articles 87 to 91 are fulfilled (Article 15d). Remains at the disposal of the EU Authorized Representative and shall suffer no disadvantage within the manufacturer's organization in relation to the proper fulfilment of his/her duties. Minimum of a Bachelor's degree Minimum of 10 years of Quality engineering experience in a medical device or regulated environment or similar related work experience Minimum of 5 years of previous direct or indirect management experience Demonstrated ability to lead effectively across a broad set of cross-functional partners/teams and diverse body of work/functions/sites. Advanced degree preferred Lean business/VIP experience Demonstrated ability to be an inclusive leader with proven experience collaborating with peers Demonstrated ability to influence and drive consensus across multiple parties in a highly matrixed organization Demonstrated high degree of integrity, professionalism, and the ability to establish credibility Ability to be innovative and drive new perspectives based on industry standards and best practices High sense of urgency and commitment to execution Proven adaptability, comfortable with change and with a demonstrated ability to react and response to a fast-changing environment

Responsibilities

The Senior Quality Director is responsible for recruiting, coaching, and developing organizational talent while fostering a diverse workplace. They will provide direction and guidance to team members to achieve individual, project, and team goals, ensuring compliance with quality management systems and regulatory obligations.