Quality Assurance Engineer
7 days ago
At EnChannel Medical, we are pushing the boundaries of cardiac arrhythmia treatment. Our goal is to solve real-world problems and maximize global impact by leveraging technology. We are seeking a highly skilled and motivated individual to join our team as a Quality Lead for multiple electrophysiology (EP) catheter programs. In this role, you will be responsible for ensuring the highest standards of quality across these programs, from design to post-market surveillance.
Key Responsibilities:- Act as the Quality Lead for multiple EP catheter programs, providing direction and oversight to ensure product excellence.
- Develop comprehensive Technical Documentation for Medical Device Files, including Requirements Documents, Risk Management plans, Protocols, IFUs/User Manuals, V&V plans, and Traceability Matrices.
- Drive assessments and validations for design verification test methods, ensuring robust and reliable testing processes.
- Participate in engineering feasibility testing and official product testing, overseeing third-party testing where appropriate, and generating detailed reports with risk-based statistical analysis.
- Support post-market surveillance activities, manage complaints, and continuously improve product quality.
- 5+ years of experience in quality assurance within the medical device industry or a regulated industry, preferably with experience in aerospace.
- Bachelor's degree in an engineering or life sciences discipline, or an equivalent combination of education and experience.
- In-depth knowledge of medical device regulations and standards, including ISO 13485 and FDA 21 CFR Part 820.
- Proven experience with electrophysiology (EP) catheter programs and proficiency in risk management, test method validation, and statistical data analysis.
- Strong leadership and communication skills, with excellent technical writing abilities and attention to detail.
We are an E-Verify and equal opportunity employer. We believe in hiring a diverse workforce and sustaining an inclusive, people-first culture. Our company is committed to non-discrimination on any protected basis, including disability and veteran status, or any basis covered under acceptable law. We offer a competitive salary, comprehensive benefits plan, and 401K with company matching.
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