Medical Device Quality Manager

📋 Description

• Responsible for quality of assigned combination products and medical devices
• Ensures delivery of quality elements needed to facilitate on-market support
• Supports Global Product Quality Assurance strategy and implements agreed strategy
• Makes key decisions on product quality, compliance and regulatory conformance issues
• Leads collection, verification and improvement of Quality metrics
• Leads a team of SMEs and provides oversight for project activities

🎯 Requirements

• Bachelor's Degree in relevant Life Science or other technical field required; Graduate degree
• Minimum 7+ years in Quality Assurance Operations Management, Regulatory, Operations, or Technical
• Strong analytical and problem-solving skills, positive interpersonal skills
• Strong quality assurance/control, manufacturing, laboratory, technical support, regulatory, and/or
• Experience with third-party external manufacturing requirements

🎁 Benefits

• Comprehensive benefits package including paid time off, medical/dental/vision insurance, and 401(k)
• Eligible to participate in long-term incentive programs