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Philips · 3 days ago

Senior Manager, Design Assurance Engineering

San Diego, CA

Full-time

Onsite

Senior Level, Lead/Staff

$128K/yr - $180K/yr

8+ years exp

Philips is a health technology company dedicated to improving access to quality healthcare. The Senior Manager of Design Assurance Engineering will oversee the Quality Management System to support the design controls process during the development of new medical devices, ensuring compliance and continuous improvement within the design assurance team.

B2BConsumer ElectronicsElectronicsLightingWellness

No H1B

Responsibilities

Drive engagement within and develop Design Assurance team members. Work with teams and other Design Assurance team members to ensure compliance to the QMS

Ensure that NPI projects are adequately staffed and supported. Build stable relationships internally. Manage department to budget

Understand and implement processes and intent of all aspects of the QMS related to Design Controls

Using engineering principles, analyze situations or data to identify gaps between project work and QMS. Lead and support Corrective and Preventive Actions (CAPA) and QMS continuous improvement projects

Develop mastery of our products and analyze complaint data, post market surveillance and risk analysis to assist in the identification of potential product improvements based on sound engineering principles

Qualification

Quality Management System (QMS)Design ControlsISO 13485ISO 14971Statistical AnalysisRisk ManagementTeam DevelopmentLeadershipProject Management

Required

8+ years' experience in Quality Assurance, Design Engineering, Systems Engineering, or similar in a highly regulated industry

5+ years' experience with a MS or higher

3+ years' experience leading and managing people

Strong understanding of design quality tools, methods and activities

Demonstrated expertise in managing complex projects and implementing cultural change

You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this Office/Remote position