Manager, Design Quality Late-Stage Development

📋 Description

• Serves as the primary quality lead for project activities and the team members (within and outside
• Assure proper integration and support of device regulations, drug regulations and as appropriate
• Perform design control activities: Mentor/lead product team members through the design process
• Ensure design control documentation (Traceability/Linkages) & design change control
• Identify gaps in existing processes as well as the need for new processes. Lead cross-functional
• Guide project development as a team member in global and local product development teams for

🎯 Requirements

• Bachelor's Degree in relevant Engineering, Life Science or other technical discipline or equivalent
• 7+ years of total combined experience.; At least 5 years in Operations Quality Assurance, 3 years
• Knowledge and a comprehensive understanding of combination products, medical devices and
• Understanding of regulations and standards affecting combination products and medical devices
• Sound technical understanding of product development (e.g. approaches for definition of
• Well-versed in risk management methodologies and their application.

🎁 Benefits

• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick)
• This job is eligible to participate in our long-term incentive programs.
• Note: No amount of pay is considered to be wages or compensation until such amount is earned
• Equal Opportunity Employer/Veterans/Disabled.