Manager, Post-Market Quality

Element Science is a medical device and digital health company redefining how patients with heart disease are monitored and treated as they transition from the hospital to the home. The Post Market Quality Manager is responsible for the end-to-end lifecycle of product feedback and quality issues, including complaint initialization, investigation, reportability, and closure, while maintaining regulatory compliance.

Requirements

• Bachelor’s degree in Engineering, Life Sciences, or a related technical field
• 5+ years in Quality Assurance or Regulatory Affairs within a regulated industry (Medical Device, Biotech, or Pharma) with 2+ years of managing direct reports
• Familiarity with CMS DMEPOS Quality Standards
• Deep expertise in FDA 21 CFR Part 803 (MDR), Part 820, and ISO 13485/14971
• Working knowledge of EU MDR Vigilance reporting obligations
• Experience managing complaints in a validated electronic management system or quality management system (e.g. Salesforce, Master Control, ETQ or equivalent)
• Proficiency in statistical trending, complaint metrics, and data visualization tools, including excel
• Ability to present complex post-market data clearly to management and cross functional stake holders

Benefits

• Stock Options
• 90% employer-paid medical, dental, and vision insurance
• Company-paid Basic Life Insurance
• 401(k) retirement plan (Traditional and Roth)
• Competitive Paid Time Off
• Paid Holidays
• FSA (Flexible Spending Accounts)
• HSA (Health Savings Account)
• Employee Assistance Program through PEO