Are you interested in working with the World’s leading AI-powered Quality Engineering Company? Ready to advance your career, team up with global thought leaders across industries and make a difference every day? Join us at Qualitest!
Qualitest is seeking a Lead Specialist - for our team.
- Develop and execute comprehensive verification and validation protocols for medical devices, including software, hardware, and system components.
- Collaborate with cross-functional teams including R&D, Quality Assurance, Regulatory Affairs, and Manufacturing to ensure alignment with project requirements and regulatory standards.
- Conduct risk assessments and develop risk mitigation strategies throughout the product development lifecycle.
- Design and execute test cases to verify and validate system functionality, performance, and reliability.
- Analyze test results, identify issues, and work with the development team to implement corrective actions.
- Maintain thorough documentation of verification and validation activities in compliance with regulatory requirements.
- Stay updated on industry standards, regulations, and best practices related to medical device development and testing.
- Support regulatory submissions by providing documentation and evidence of verification and validation activities.
- Qualifications:
B
Requirements
- Bachelor's degree in Biomedical Engineering, Electrical Engineering, Computer Science, or related field. Master's degree preferred.
- Minimum of X years of experience in verification and validation of medical devices, preferably in a regulated environment (FDA, ISO, etc.).
- In-depth knowledge of medical device regulations and standards such as FDA 21 CFR Part 820, ISO 13485, IEC 62304, and IEC 60601.
- Experience with software testing methodologies, including test case design, test execution, and defect tracking.
- Strong analytical and problem-solving skills with a keen attention to detail.
- Excellent communication and collaboration skills with the ability to work effectively in a cross-functional team environment.
- Familiarity with risk management processes, including FMEA, FTA, and risk analysis tools.
- Experience with medical device development lifecycle processes, including design controls and verification/validation documentation.
- Prior experience with automated testing tools and scripting languages is a plus.
Benefits
Why Qualitest?
- Founded in 1997, Qualitest offers a wide range of digital quality solutions designed to provide enterprise customers with end-to-end quality management services across the software lifecycle. Qualitest achieves this by deploying engagement models tailored to the precise quality engineering needs of technology platforms in the financial services, health services, telecom, technology, retail, media, gaming, and utilities industries. It has operations in the US, UK, India, Germany, Romania, Israel, Argentina, Mexico, Switzerland, and Portugal, and serves over 400 blue-chip customers worldwide.
- We provide industry-leading managed services that drive Quality for Quality Assurance and Testing of hardware devices, software apps and experiences as well as Ground Truth Data Services for artificial intelligence (AI) and machine learning (ML)
- Be a part of a company who strives to support for diversity and inclusion in the workplace – we are one, we are many at Qualitest. Celebrate culture, share knowledge with engineers from around the globe, and inspire each other through our differences. We have more than 40% women and around 120 different nationalities.
- Local and global opportunities – we offer you internal rotation and international mobility opportunities to grow your career.
- Clear view of your career and progression with the company – Qualitest is growing massively (since 2021 – tripled our employees base – we now have more than 8,000 engineers) and giving you the opportunity to grow with us.
- Work hard and play harder with our flexible and casual culture. Take a break from work and join an employee event, or enjoy the amenities and games provided from one of our Employees Centers.
- Never stop experimenting and learning with QCraft – our Learning & Development platform: 50,000+ courses, 300+ virtual labs, mentorship and leadership programs, professional tribes, sponsored certifications, and much more
- A Competitive pay, the salary range for the role is $75,000-$85,000.
- Earn bonuses via our Client Referral and Employee Referral Program’s. Refer and earn – tap your network for net-worth.
- We recognize our employees work via our Qudos platform - You can earn bonuses and spot awards by celebrating your and your peers’ achievements.
- Save your earnings and prepare for your future by enrolling in our 401k plan where Qualitest will match your contributions accelerating your savings plan.
- Life and disability insurance.
- Take care of your health with enrollment into one of our competitive healthcare benefits
