Sr QA Manager

Join a Leading Deep-Tech Startup in Silicon Valley as a Senior QA Manager

Are you ready to take your career to the next level with a progressive deep-tech startup in Silicon Valley? Our client, a cutting-edge company known as LEADOPTIK Inc., is revolutionizing the field of imaging technology to enhance the accuracy of minimally invasive procedures. As a Senior QA Manager, you will play a crucial role in ensuring that products are developed and manufactured in compliance with quality standards and regulatory requirements.

About LEADOPTIK Inc.:
Located in Silicon Valley, LEADOPTIK Inc. is a forward-thinking startup dedicated to developing a miniature imaging platform to improve medical procedures. Join a multidisciplinary team focused on innovation and excellence in the medical technology industry.

Responsibilities:

• Manage the company's Quality Management System, implementing continuous improvements
• Provide guidance and expertise to junior team members in QA processes
• Oversee regulatory submissions for Class-II medical devices for FDA approval
• Develop and validate test methods to ensure device design integrity
• Investigate and implement corrective actions for quality issues
• Conduct audits of suppliers to ensure compliance with quality standards
• Perform statistical analysis to drive decision-making processes
• Enforce compliance with quality and regulatory requirements

Requirements:

• Experience in the medical device industry
• ASQ Certified Quality Engineer preferred
• Proficiency in MS Word, MS Excel
• Strong analytical and leadership skills
• Ability to work under pressure and manage multiple projects
• Knowledge of FDA regulations and ISO standards

Salary:
This role offers a competitive base salary of £155,000.00, commensurate with experience.

Benefits:

• Medical, dental, and vision insurance
• 401(K) plan

Location:
San Jose, CA 95131 (On-site with occasional travel)

Human Review Note:
When you apply, a real person from our team will review your details and reach out. We value transparency, fairness, and human connection in our recruitment process.