Design Quality Manager - Interventional Oncology & Embolization at Boston Scientific Corporation Malaysia

Maple Grove, Minnesota, United States -

Full Time

Start Date

Immediate

Expiry Date

20 Feb, 26

Salary

0.0

Posted On

22 Nov, 25

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Design Controls, Risk Management, NCEP/CAPA, Post-Market Surveillance, FDA Regulations, ISO Medical Device Regulations, Project Management, Technical Leadership, Collaboration, Quality Assurance, Sustaining Engineering, New Product Development, Coaching, Diversity, Compliance, Patient Safety

Industry

Medical Equipment Manufacturing

Description

Your Responsibilities will include: Assists in and/or manages functional deliverables and ensures technical excellence for Sustaining Engineering and New Product Development. Provides leadership, guidance, and approval regarding Quality initiatives including product performance. Works cross-functionally in identifying and resolving technical issues, takes a proactive role in collaborating across the organization to mitigate issues. Works with project managers and functional leaders (R&D, Supplier Quality Engineering, Marketing, and Regulatory) to understand priorities, plan resources, and allocate time. Leads a group or team of employees in the achievement of organizational goals. Guide, coach, direct, and develop direct reports, and drive best practices throughout their organization. Fosters a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives. Directs and controls the activities and budget of one or more functional areas and/or projects/programs. Monitors and ensures compliance with company policies and procedures (e.g. federal/country and regulatory requirements). Influences others to build collaborative relationships, achieve goals and effectively guide them to understand more complex issues. In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures. B.S. Degree in engineering such as Mechanical Engineering, Electrical Engineering, Materials Science and/or Biomedical Engineering. Bachelor's degree plus 8 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, commercial launch, and product sustainment. Knowledge/Experience of Design Controls, Risk Management, NCEP/CAPA, Post-Market Surveillance, and FDA/ISO Medical Device Regulations. 2+ years of experience mento

Responsibilities

The Design Quality Manager will assist in managing functional deliverables and ensure technical excellence for Sustaining Engineering and New Product Development. They will lead cross-functional collaboration to identify and resolve technical issues while guiding and developing their team to achieve organizational goals.