Quality Process Validation Engineer

Quality Systems     ·     Fremont, CA    ·    Full time

As a Quality Process Validation Engineer at Neuralink, you will be a part of the Quality Systems team responsible for supporting cross-functional teams in process validation related to medical devices. You will be in charge of communicating with experts to validate processes like cleaning, sterility, and packaging.

Key Responsibilities:

• Responsible for medical device cleaning, sterility, and packaging-process validation.
• Develop, design, and execute validation protocols.
• Have a working knowledge of 21 CFR 820.
• Drive Quality Engineering Validation activities designed to make it easier for design engineers to innovate.
• Be an excellent communicator who can clearly and effectively translate regulatory requirements into action.
• Have a clear understanding of how to apply risk-mitigation strategies.
• Have advanced knowledge in the areas of Quality Assurance, Process Validation, Design Controls, Risk Management, and Statistical Techniques.
• Display excellent people skills.

Skill/Job Requirements:

• Minimum BS degree; Minimum of 2 years of regulated process validation experience.
• Very high energy.
• Extremely good with people.
• Excellent creative problem-solving skills.
• Excellent at putting plans into action.
• Prefer ASQ certification, ie. CQE

What we offer:

• An opportunity to change the world and work with some of the smartest and the most talented experts from different fields. 
• Growth potential. We rapidly advance team members who have an outsized impact. 
• Excellent medical, dental, and vision insurance through a PPO plan; parental leave.
• Flexible time off + paid holidays.
• Equity + 401(k) plan.
• Commuter Benefits.
• Meals provided.

Neuralink provides equal opportunity in all of our employment practices to all qualified employees and applicants without regard to race, color, religion, gender, national origin, age, disability, marital status, military status, genetic information or any other category protected by federal, state and local laws.  This policy applies to all aspects of the employment relationship, including recruitment, hiring, compensation, promotion, transfer, disciplinary action, layoff, return from layoff, training and social, and recreational programs. All such employment decisions will be made without unlawfully discriminating on any prohibited basis.