Employer Industry: Medical Technology

Why consider this job opportunity:
- Competitive compensation with a combination of salary and bonus potential
- Opportunity for career advancement and growth within the organization
- Hybrid work environment with the flexibility to work remotely
- Comprehensive benefits package including health insurance, stock options, and paid time off
- Collaborative and supportive team focused on innovative solutions
- Chance to work on a life-changing product that improves patient outcomes

What to Expect (Job Responsibilities):
- Lead design changes, nonconformances, CAPA's, and field actions
- Evaluate product feedback, complaints, and adverse event reports for trends
- Monitor post-market data related to device performance and safety
- Maintain quality system software and ensure proper documentation storage
- Participate in site audit/inspection readiness and response activities

What is Required (Qualifications):
- Knowledge of 21 CFR 820 and/or ISO 13485 quality systems
- Strong communication and interpersonal skills
- Project management and organizational skills
- Ability to work independently in a dynamic environment
- Experience in a FDA-regulated environment

How to Stand Out (Preferred Qualifications):
- Knowledge of digital health technologies or medical device reimbursement
- Understanding of health care compliance, HIPAA, and information security

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