Senior Manager, Quality Systems

Job Summary

A company is looking for a Senior Manager, Quality Systems - Design Controls Global Process Owner.

Key Responsibilities

• Lead the design and implementation of company-wide Design Controls processes and related technologies
• Establish governance and alignment by partnering with various leaders and business partners
• Serve as the Design Controls process expert for regulatory inspections and guide teams in process improvement

Required Qualifications

• Bachelor's degree in Engineering, Computer Science, Software Engineering, Life Sciences, or a related technical discipline
• Minimum 10 years of experience in medical device design and development within a regulated environment
• Minimum 5 years of technical leadership supporting design engineering and/or design controls
• Direct experience with medical device regulatory requirements
• Experience designing and implementing quality system processes for regulated medical devices