Senior Manager – QA Failure Analysis

Senior Manager – QA Failure Analysis

Requirements

• Bachelor’s degree in STEM or Quality related education or an engineering discipline required, Master’s degree preferred.
• At least 12+ years of progressive experience in quality engineering or Product Development prefer medical device
• 3+ years of experience leading technical teams and/or managerial supervisory experience
• Must be familiar with 21CFR 820, ISO13485, EU‐MDR requirements for manufacturers.
• ASQ CQE, CQA, Black Belt Six Sigma certification a plus
• Demonstrated reasoning ability to apply principles of logical or scientific and critical thinking
• Demonstrated ability to be a proactive and collaborative leader in a dynamic operations and engineering environment.
• Able to multi‐task, establish clear expectations, set objectives and deliver results within tight deadlines.
• Excellent interpersonal and communication skills across all levels of the organization.
• Must be able to work in a dynamic, fast‐paced environment with strong ability to establish technical and professional credibility and demonstrate MUST‐DO attitude.
• Must be able to manage and resolve conflicting product and project requirements and be a strong team player with ability to collaborate across functional areas.

Responsibilities

• Manage and direct work failure analysis resources, personnel and FA lab, for testing of electromechanical devices.
• This role will be responsible for the hiring, development, and performance management of the failure analysis team.
• Plan annual budget to ensure resources are adequate to execute approved projects and goals.
• Provide leadership, coaching and development plans for direct reports to maintain an engaged and productive team.
• Create, apply, and monitor performance metrics for personnel, product, and processes.
• Create, manage, and improve failure analysis processes to evaluate returned products / in-house product issues and generate robust complaint investigation reports.
• Provide data driven insights on product issues and lead cross functional teams to successful and timely issue resolution.
• Support complaint handling program, including complaint analysis, and device investigations.
• Review product designs and process documentation for improving quality characteristics, including manufacturability, serviceability, testability, reliability, and conformance to product and quality system requirements.
• Prioritize activities related to failure investigations including review and approval of failure analysis investigation reports.

Preferred Qualifications

• Master’s degree preferred.
• ASQ CQE, CQA, Black Belt Six Sigma certification a plus.