Lead Specialist
ZenQ
- Concord, CA
- $75,000-85,000 per year
- Permanent
- Full-time
- 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:
- 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.
- Founded in 1997,
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